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FDA 510(k)

CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4

K-Number: K901475 · 1990-06-20

ApplicantBaxter Healthcare Corp
Decision Date1990-06-20
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-06-20 under 510(k) number K901475. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4?

CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K901475.

When did CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 receive FDA 510(k) clearance?

CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 received FDA 510(k) clearance on 1990-06-20, under 510(k) number K901475.

Who is the listed applicant for CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4?

The FDA product code for CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 is CDX.

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Related Devices (Code: CDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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