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

Kit, Identification, Mycobacteria

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

JSY is the FDA product code for Kit, Identification, Mycobacteria, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JSY
Device name
Kit, Identification, Mycobacteria
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
5
Ingested recalls
1

Clearances, product code JSY

By decision year
5 clearances under product code JSY with a decision year between 1983 and 1995, 1995 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JSY by decision year
YearClearances
19831
19881
19953

Applicants with the most clearances

Product code JSY
Applicants holding the most 510(k) clearances under product code JSY
ApplicantClearances
Dynagen, Inc.3
Alpha-Tec Systems, Inc.1
Analytical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code