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

Culture Media, Non-Selective And Differential

21 CFR 866.2320 / Microbiology
FDA source (opens on fda.gov)

JSH is the FDA product code for Culture Media, Non-Selective And Differential, a class I device type, regulated under 21 CFR 866.2320. As of , FDA records hold 146 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JSH
Device name
Culture Media, Non-Selective And Differential
Regulation
21 CFR 866.2320
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
146
Ingested recalls
2

Clearances, product code JSH

By decision year
146 clearances under product code JSH with a decision year between 1977 and 1988, 1985 the highest year at 34.
Show the numbers
510(k) clearances under FDA product code JSH by decision year
YearClearances
19772
19781
197921
19808
19816
198214
198315
198413
198534
198611
198713
19888

Applicants with the most clearances

Product code JSH
Applicants holding the most 510(k) clearances under product code JSH
ApplicantClearances
Neogen Culture Media21
Isle Media and Sterile Products, Inc.17
bioMerieux, Inc.12
BD Becton Dickinson Vacutainer Systems Preanalytic10
Otisville Biotech, Inc.9
Apl Medical Supplies8
Hardy Media7
Micro Media Laboratories7
Gibco Laboratories Life Technologies, Inc.5
Granite Diagnostics, Inc.5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order