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FDA 510(k)

STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC

K-Number: K932912 · 1993-10-28

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-10-28
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC 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 1993-10-28 under 510(k) number K932912. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC?

STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC is a medical device that received FDA 510(k) clearance on 1993-10-28. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K932912.

When did STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC receive FDA 510(k) clearance?

STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC received FDA 510(k) clearance on 1993-10-28, under 510(k) number K932912.

Who is the listed applicant for STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC?

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 FREE THYROXINE (FREE T4) FLUOROMETRIC?

The FDA product code for STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC is CEC.

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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: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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