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

Kit, Fastidious Organisms

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

JST is the FDA product code for Kit, Fastidious Organisms, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
JST
Device name
Kit, Fastidious Organisms
Regulation
21 CFR 866.2660
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
6
Ingested recalls
6

Clearances, product code JST

By decision year
6 clearances under product code JST with a decision year between 1983 and 1996, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JST by decision year
YearClearances
19833
19841
19861
19961

Applicants with the most clearances

Product code JST
Applicants holding the most 510(k) clearances under product code JST
ApplicantClearances
Austin Biological Laboratories2
Becton Dickinson Microbiology Systems1
Dms Products, Inc.1
Granite Diagnostics, Inc.1
Oxoid U.S.A., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code