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

Antigens, Ha, Echovirus 1-34

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

GNJ is the FDA product code for Antigens, Ha, Echovirus 1-34, a class I device type, regulated under 21 CFR 866.3205. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GNJ
Device name
Antigens, Ha, 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
1
Ingested recalls
0

Clearances, product code GNJ

By decision year
1 clearance under product code GNJ with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GNJ by decision year
YearClearances
19831

Applicants with the most clearances

Product code GNJ
Applicants holding the most 510(k) clearances under product code GNJ
ApplicantClearances
JEDMED Instrument Company1

Companies listing this code with FDA

Companies whose registered establishments list this code

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