REDI-TEST OPIATES


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K991883
Device Name REDI-TEST OPIATES
Applicant
ADVANTAGE DIAGNOSTICS CORP.
3573 westwind blvd.
santa rosa, 
CA 
95403

Applicant Contact janis freestone
Correspondent
ADVANTAGE DIAGNOSTICS CORP.
3573 westwind blvd.
santa rosa, 
CA 
95403

Correspodent Contact janis freestone
Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 06/02/1999
Decision Date 09/15/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No