510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JSXClass I

Kit, Identification, Neisseria Gonorrhoeae

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

JSX is the FDA product code for Kit, Identification, Neisseria Gonorrhoeae, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JSX
Device name
Kit, Identification, Neisseria Gonorrhoeae
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
16
Ingested recalls
1

Clearances, product code JSX

By decision year
16 clearances under product code JSX with a decision year between 1978 and 1996, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JSX by decision year
YearClearances
19781
19791
19812
19833
19853
19871
19882
19911
19921
19961

Applicants with the most clearances

Product code JSX
Applicants holding the most 510(k) clearances under product code JSX
ApplicantClearances
Abbott Medical1
Analytical Products, Inc.1
Austin Biological Laboratories1
Carr-Scarborough Microbiologicals, Inc.1
Culture Kits, Inc.1
E-Y Laboratories, Inc.1
Innovative Diagnostic Systems, Inc.1
Kev Connecticut Diagnostics, Inc.1
Medtex Laboratories, Inc.1
Micro-Bio-Logics1

Companies listing this code with FDA

Companies whose registered establishments list this code