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

Reagent, Russel Viper Venom

21 CFR 864.8950 / Hematology
FDA source (opens on fda.gov)

GIR is the FDA product code for Reagent, Russel Viper Venom, a class I device type, regulated under 21 CFR 864.8950. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GIR
Device name
Reagent, Russel Viper Venom
Regulation
21 CFR 864.8950
Device class
Class I
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
16
Ingested recalls
1

Clearances, product code GIR

By decision year
16 clearances under product code GIR with a decision year between 1984 and 2014, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GIR by decision year
YearClearances
19841
19901
19933
19951
19993
20002
20061
20101
20111
20142

Applicants with the most clearances

Product code GIR
Applicants holding the most 510(k) clearances under product code GIR
ApplicantClearances
Dsrv, Inc.2
Gradipore, Ltd.2
Instrumentation Laboratory Co.2
Precision BioLogic Inc.2
Sigma Diagnostics, Inc.2
Sekisui Diagnostics, LLC1
Biopool AB1
Diagnostica Stago, Inc.1
Diatech, Inc.1
Graoipore, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code