ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT


Device Classification Name

system,test,biotinidase

510(k) Number K080294
Device Name ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
Applicant
ASTORIA-PACIFIC,INC.
15130 s.e. 82nd dr.
clackamas, 
OR 
97015

Applicant Contact jason reynolds
Correspondent
ASTORIA-PACIFIC,INC.
15130 s.e. 82nd dr.
clackamas, 
OR 
97015

Correspodent Contact jason reynolds
Regulation Number 862.1118
Classification Product Code
NAK  
Date Received 02/04/2008
Decision Date 11/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No