CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4— 510(k) K901475

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K901475 for CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4, Substantially Equivalent on 1990-06-20. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CDX
Advisory panel: Clinical Chemistry
Date received: 1990-03-27
Decision date: 1990-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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