ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119


codes

Device Classification Name

reagent, russel viper venom

510(k) Number K000528
Device Name ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
Original Applicant
SIGMA DIAGNOSTICS, INC.
545 south ewing ave.
st. louis, 
MO 
63103

Original Contact william r gilbert
Regulation Number 864.8950
Classification Product Code
GIR  
Date Received 02/17/2000
Decision Date 04/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No