ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET— 510(k) K121533

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K121533 for ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET, Substantially Equivalent on 2012-06-15. Applicant: Tosoh Bioscience, Inc..

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code LPS
Advisory panel: Clinical Chemistry
Date received: 2012-05-24
Decision date: 2012-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

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