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

Antigens, All, Leptospira Spp.

21 CFR 866.3350 / Microbiology
FDA source (opens on fda.gov)

GRY is the FDA product code for Antigens, All, Leptospira Spp., a class II device type, regulated under 21 CFR 866.3350. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GRY
Device name
Antigens, All, Leptospira Spp.
Regulation
21 CFR 866.3350
Device class
Class II
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 GRY

By decision year
2 clearances under product code GRY with a decision year between 1988 and 2000, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GRY by decision year
YearClearances
19881
20001

Applicants with the most clearances

Product code GRY
Applicants holding the most 510(k) clearances under product code GRY
ApplicantClearances
Hillcrest Biologicals1
Panbio Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code