PRIMIDONE EIA TEST


Device Classification Name

radioimmunoassay, amphetamine

510(k) Number K960526
Device Name PRIMIDONE EIA TEST
Applicant
DIAGNOSTIC REAGENTS, INC.
601 california ave.
sunnyvale, 
CA 
94086

Applicant Contact yuh-geng tsay
Correspondent
DIAGNOSTIC REAGENTS, INC.
601 california ave.
sunnyvale, 
CA 
94086

Correspodent Contact yuh-geng tsay
Regulation Number 862.3100
Classification Product Code
DJP  
Date Received 02/06/1996
Decision Date 03/18/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized