DOCUMENT TDM ULTRA ASSAYED CONTROL


Device Classification Name

drug mixture control materials

510(k) Number K960244
Device Name DOCUMENT TDM ULTRA ASSAYED CONTROL
Applicant
CASCO STANDARDS
p.o. box 970
yarmouth, 
ME 
04096 -1970

Applicant Contact christine v beach
Correspondent
CASCO STANDARDS
p.o. box 970
yarmouth, 
ME 
04096 -1970

Correspodent Contact christine v beach
Regulation Number 862.3280
Classification Product Code
DIF  
Subsequent Product Codes
DKC   LAX   LAZ   LBA  
Date Received 01/16/1996
Decision Date 03/22/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No