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

Antisera, Cf, Echovirus 1-34

21 CFR 866.3205 / Microbiology
FDA source (opens on fda.gov)

GNK is the FDA product code for Antisera, Cf, Echovirus 1-34, a class I device type, regulated under 21 CFR 866.3205. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GNK
Device name
Antisera, Cf, Echovirus 1-34
Regulation
21 CFR 866.3205
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
3
Ingested recalls
0

Clearances, product code GNK

By decision year
3 clearances under product code GNK with a decision year between 1985 and 1985, 1985 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GNK by decision year
YearClearances
19853

Applicants with the most clearances

Product code GNK
Applicants holding the most 510(k) clearances under product code GNK
ApplicantClearances
Hillcrest Biologicals3

Companies listing this code with FDA

Companies whose registered establishments list this code

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