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

Culture Media, Non-Propagating Transport

21 CFR 866.2390 / Microbiology
FDA source (opens on fda.gov)

JSM is the FDA product code for Culture Media, Non-Propagating Transport, a class I device type, regulated under 21 CFR 866.2390. As of , FDA records hold 111 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
JSM
Device name
Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
111
Ingested recalls
18

Clearances, product code JSM

By decision year
111 clearances under product code JSM with a decision year between 1979 and 2025, 1986 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code JSM by decision year
YearClearances
19794
19803
19822
19832
19844
19859
198610
19876
19884
19892
19914
19921
19948
19956
19964
19976
19991
20011
20033
20041
20121
20154
20162
20171
20181
20211
20225
20233
20249
20253

Applicants with the most clearances

Product code JSM
Applicants holding the most 510(k) clearances under product code JSM
ApplicantClearances
COPAN Diagnostics, Inc.8
Ncs Diagnostics, Inc.7
Medical Packaging Corporation6
Remel Inc6
Copan Italia5
Precision Dynamics Corporation5
BD Becton Dickinson Vacutainer Systems Preanalytic4
Isle Media and Sterile Products, Inc.4
Microtest4
Puritan Medical Products Company, LLC4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 65 companies shown, in name order