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

Culture Media, Single Biochemical Test

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

JSF is the FDA product code for Culture Media, Single Biochemical Test, a class I device type, regulated under 21 CFR 866.2320. As of , FDA records hold 87 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JSF
Device name
Culture Media, Single Biochemical Test
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
87
Ingested recalls
0

Clearances, product code JSF

By decision year
87 clearances under product code JSF with a decision year between 1978 and 1988, 1984 the highest year at 24.
Show the numbers
510(k) clearances under FDA product code JSF by decision year
YearClearances
19784
19795
19801
19814
198213
19831
198424
198510
19864
19877
198814

Applicants with the most clearances

Product code JSF
Applicants holding the most 510(k) clearances under product code JSF
ApplicantClearances
Hardy Media20
Irvine Diagnostic Services10
Granite Diagnostics, Inc.7
bioMerieux, Inc.7
Carr Microbiologicals4
Otisville Biotech, Inc.4
Austin Biological Laboratories3
Difco Laboratories, Inc.3
Isle Media and Sterile Products, Inc.3
Remel Co.3

Companies listing this code with FDA

Companies whose registered establishments list this code