Product code GIR— Hematology
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
- Classification name
- Reagent, Russel Viper Venom
- Device class
- Class 1
- Regulation
- 21 CFR 864.8950
- Advisory panel
- Hematology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code GIR
FDA has cleared devices under product code GIR between 1984 and 2014, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2014
- 2011
- 2010
- 2006
- 2000
- 1999
- 1995
- 1993
- 1990
- 1984
Top applicants under product code GIR
Recent clearances under product code GIR
- K132076 — REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
- K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREEN
- K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
- K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
- K061805 — STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
- K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
- K000528 — ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
- K990580 — CRYOCHECK LA SURE, MODEL SUR25-10
- K990579 — CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
- K990302 — IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
- K940490 — DV TEST AND DVV CONFIRM
- K932463 — BIOCLOT LA
- K922156 — LUCOR CONFIRMATORY REAGENT
- K922326 — LUPO-TEST REGEANT
- K903037 — LUPO-TEST REAGENT
- K841365 — DIA REPTIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.