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

Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6

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

GNG is the FDA product code for Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6, a class I device type, regulated under 21 CFR 866.3145. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GNG
Device name
Antigens, Cf (Including Cf Control), 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
2
Ingested recalls
0

Clearances, product code GNG

By decision year
2 clearances under product code GNG with a decision year between 1985 and 1992, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GNG by decision year
YearClearances
19851
19921

Applicants with the most clearances

Product code GNG
Applicants holding the most 510(k) clearances under product code GNG
ApplicantClearances
Hillcrest Biologicals1
Virion (U.S.), Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GNG.