Product code JSJ: 510(k) clearances and predicates
Product code JSJ covers POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421. FDA lists 307 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
307 clearances on file under product code JSJ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JSJ clearances in the FDA index, with applicant and decision date:
- K882463, POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421, applicant Lakewood Biochemical Co., Inc., decided 1988-06-22. FDA record
- K881544, LITTMAN AGAR, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881561, TERGITOL 7 BROTH, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881526, CHAPMAN STONE MEDIUM, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881571, YM BROTH, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881578, STREPTOSEL, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881549, MYCOLOGICAL AGAR W/LOW PH, applicant Acumedia Manufacturers, Inc., decided 1988-04-18. FDA record
- K881565, INHIBITORY MOLD AGAR, 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 LITTMAN AGAR, TERGITOL 7 BROTH. Watch new JSJ 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 JSJ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JSJ clearances include POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421.
How many 510(k) clearances use product code JSJ?
307 at the time this page was generated, from openFDA records.
How do I find a predicate device under JSJ?
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 JSJ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.