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

Culture Media, Selective And Non-Differential

21 CFR 866.2360 / Microbiology
FDA source (opens on fda.gov)

JSJ is the FDA product code for Culture Media, Selective And Non-Differential, a class I device type, regulated under 21 CFR 866.2360. As of , FDA records hold 307 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
JSJ
Device name
Culture Media, Selective And Non-Differential
Regulation
21 CFR 866.2360
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
307
Ingested recalls
6

Clearances, product code JSJ

By decision year
307 clearances under product code JSJ with a decision year between 1976 and 1988, 1987 the highest year at 58.
Show the numbers
510(k) clearances under FDA product code JSJ by decision year
YearClearances
19762
19773
19782
197913
198018
198122
198233
198329
198440
198541
198621
198758
198825

Applicants with the most clearances

Product code JSJ
Applicants holding the most 510(k) clearances under product code JSJ
ApplicantClearances
Neogen Culture Media30
Lakewood Biochemical Co., Inc.30
Hardy Media26
Otisville Biotech, Inc.23
Gibco Laboratories Life Technologies, Inc.18
bioMerieux, Inc.18
Isle Media and Sterile Products, Inc.17
BD Becton Dickinson Vacutainer Systems Preanalytic16
Micro Media Laboratories11
American Laboratory Supply, Inc.10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order