AIA-PACK B12 ASSAY— 510(k) K964348

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K964348 for AIA-PACK B12 ASSAY, Substantially Equivalent on 1997-01-13. Applicant: Tosoh Medics, Inc..

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 1996-10-31
Decision date: 1997-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

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