AIA-PACK FOLATE ASSAY— 510(k) K964349

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K964349 for AIA-PACK FOLATE ASSAY, Substantially Equivalent on 1996-11-27. Applicant: Tosoh Medics, Inc..

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code CGN
Advisory panel: Clinical Chemistry
Date received: 1996-10-31
Decision date: 1996-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.