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
GNMClass I

Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

21 CFR 866.3145 / Microbiology
FDA source (opens on fda.gov)

GNM is the FDA product code for Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6, a class I device type, regulated under 21 CFR 866.3145. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GNM
Device name
Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Regulation
21 CFR 866.3145
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
9
Ingested recalls
0

Clearances, product code GNM

By decision year
9 clearances under product code GNM with a decision year between 1995 and 1995, 1995 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code GNM by decision year
YearClearances
19959

Applicants with the most clearances

Product code GNM
Applicants holding the most 510(k) clearances under product code GNM
ApplicantClearances
Chemicon Intl., Inc.5
Light Diagnostics4

Companies listing this code with FDA

Companies whose registered establishments list this code