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FDA 510(k)

STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

K-Number: K933426 · 1993-08-26

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-08-26
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-08-26 under 510(k) number K933426. 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 STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO?

STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO is a medical device that received FDA 510(k) clearance on 1993-08-26. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K933426.

When did STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO receive FDA 510(k) clearance?

STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO received FDA 510(k) clearance on 1993-08-26, under 510(k) number K933426.

Who is the listed applicant for STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO?

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

What is the FDA product code for STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO?

The FDA product code for STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO is CDX.

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Other records listing Baxter Diagnostics, Inc. as applicant

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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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.K931295IQ TT4 ASSAYBecton Dickinson Advanced Diagnostics

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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