ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET


Device Classification Name

urinary homocystine (nonquantitative) test system

510(k) Number K121533
Device Name ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
Applicant
Tosoh BioScience, Inc.
6000 shoreline court
suite 101
south san francisco, 
CA 
94080

Applicant Contact robert wick
Correspondent
Tosoh BioScience, Inc.
6000 shoreline court
suite 101
south san francisco, 
CA 
94080

Correspodent Contact robert wick
Regulation Number 862.1377
Classification Product Code
LPS  
Subsequent Product Codes
JIT   JJX  
Date Received 05/24/2012
Decision Date 06/15/2012
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