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FDA 510(k)

ACA PLUS FREE THYROXINE(FT4) METHOD

K-Number: K962602 · 1996-08-15

ApplicantDade Intl., Inc.
Decision Date1996-08-15
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA PLUS FREE THYROXINE(FT4) METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K962602. 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 ACA PLUS FREE THYROXINE(FT4) METHOD?

ACA PLUS FREE THYROXINE(FT4) METHOD is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Dade Intl., Inc.. The 510(k) number is K962602.

When did ACA PLUS FREE THYROXINE(FT4) METHOD receive FDA 510(k) clearance?

ACA PLUS FREE THYROXINE(FT4) METHOD received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962602.

Who is the listed applicant for ACA PLUS FREE THYROXINE(FT4) METHOD?

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

What is the FDA product code for ACA PLUS FREE THYROXINE(FT4) METHOD?

The FDA product code for ACA PLUS FREE THYROXINE(FT4) METHOD is CEC.

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Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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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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