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

Supplement, Culture Media

21 CFR 866.2450 / Microbiology
FDA source (opens on fda.gov)

JSK is the FDA product code for Supplement, Culture Media, a class I device type, regulated under 21 CFR 866.2450. As of , FDA records hold 70 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
JSK
Device name
Supplement, Culture Media
Regulation
21 CFR 866.2450
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
70
Ingested recalls
6

Clearances, product code JSK

By decision year
70 clearances under product code JSK with a decision year between 1976 and 1988, 1980 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code JSK by decision year
YearClearances
19761
19781
19791
198017
198114
19827
19837
19845
19859
19865
19883

Applicants with the most clearances

Product code JSK
Applicants holding the most 510(k) clearances under product code JSK
ApplicantClearances
Oxoid U.S.A., Inc.30
Neogen Culture Media10
Gibco Laboratories Life Technologies, Inc.7
Pro-Lab, Inc.7
Flow Laboratories, Inc.3
Alpha-Tec Systems, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic2
Abbott Medical1
Bartels Immunodiagnostic Supplies, Inc.1
Central Biological Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order