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

Culture Media, Multiple Biochemical Test

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

JSE is the FDA product code for Culture Media, Multiple Biochemical Test, a class I device type, regulated under 21 CFR 866.2320. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JSE
Device name
Culture Media, Multiple 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
53
Ingested recalls
0

Clearances, product code JSE

By decision year
53 clearances under product code JSE with a decision year between 1977 and 1996, 1979 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code JSE by decision year
YearClearances
19773
19781
19797
19801
19813
19827
19837
19844
19856
19866
19873
19884
19961

Applicants with the most clearances

Product code JSE
Applicants holding the most 510(k) clearances under product code JSE
ApplicantClearances
Hardy Media7
Otisville Biotech, Inc.7
Analytical Products, Inc.5
Micro Media Laboratories5
Isle Media and Sterile Products, Inc.3
Anaerobe Systems2
Austin Biological Laboratories2
Blue Ridge Media Co.2
Carr Microbiologicals2
Granite Diagnostics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code