510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JSAClass I

Culture Media, Antibiotic Assay

21 CFR 866.2350 / Microbiology
FDA source (opens on fda.gov)

JSA is the FDA product code for Culture Media, Antibiotic Assay, a class I device type, regulated under 21 CFR 866.2350. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JSA
Device name
Culture Media, Antibiotic Assay
Regulation
21 CFR 866.2350
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code JSA

By decision year
8 clearances under product code JSA with a decision year between 1983 and 1988, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JSA by decision year
YearClearances
19833
19885

Applicants with the most clearances

Product code JSA
Applicants holding the most 510(k) clearances under product code JSA
ApplicantClearances
Neogen Culture Media8

Companies listing this code with FDA

Companies whose registered establishments list this code