DRIDAU OPIATE ASSAY


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K011150
Device Name DRIDAU OPIATE ASSAY
Original Applicant
MICROGENICS CORP.
46360 fremont blvd.
fremont, 
CA 
94538

Original Contact sherrie rinne
Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 04/16/2001
Decision Date 06/20/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No