SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT


Device Classification Name

enzymatic methods, galactose

510(k) Number K121101
Device Name SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
Applicant
ASTORIA-PACIFIC,INC.
15130 s.e. 82nd dr.
clackamas, 
OR 
97015

Applicant Contact charles a peterson
Correspondent
ASTORIA-PACIFIC,INC.
15130 s.e. 82nd dr.
clackamas, 
OR 
97015

Correspodent Contact charles a peterson
Regulation Number 862.1310
Classification Product Code
JIA  
Date Received 04/11/2012
Decision Date 06/20/2013
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