Product code JSI: 510(k) clearances and predicates
Product code JSI covers BBL CHROMAGAR 0157. FDA lists 285 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
285 clearances on file under product code JSI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JSI clearances in the FDA index, with applicant and decision date:
- K070691, BBL CHROMAGAR 0157, applicant Becton, Dickinson & CO, decided 2007-11-20. FDA record
- K974428, DIPSTREAK, applicant Novamed , Ltd., decided 1998-07-30. FDA record
- K891593, LISTERIA SELECTIVE ENRICHMENT MEDIUM, applicant Oxoid U.S.A., Inc., decided 1989-06-09. FDA record
- K890199, DENTOCULT SM-STRIP MUTANS, applicant Orion Corp., decided 1989-03-02. FDA record
- K882182, SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326, applicant Lakewood Biochemical Co., Inc., decided 1988-06-06. FDA record
- K881575, SELECTIVE STREPTOCOCCUS AGAR, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881572, XL AGAR BASE, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881555, TINSDALE AGAR BASE, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include DIPSTREAK, LISTERIA SELECTIVE ENRICHMENT MEDIUM. Watch new JSI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JSI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JSI clearances include BBL CHROMAGAR 0157.
How many 510(k) clearances use product code JSI?
285 at the time this page was generated, from openFDA records.
How do I find a predicate device under JSI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JSI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.