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FDA 510(k)

FLAGEN TM FREE T4

K-Number: K904539 · 1990-11-30

ApplicantCyberfluor, Inc.
Decision Date1990-11-30
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLAGEN TM FREE T4 is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1990-11-30 under 510(k) number K904539. 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 FLAGEN TM FREE T4?

FLAGEN TM FREE T4 is a medical device that received FDA 510(k) clearance on 1990-11-30. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K904539.

When did FLAGEN TM FREE T4 receive FDA 510(k) clearance?

FLAGEN TM FREE T4 received FDA 510(k) clearance on 1990-11-30, under 510(k) number K904539.

Who is the listed applicant for FLAGEN TM FREE T4?

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

What is the FDA product code for FLAGEN TM FREE T4?

The FDA product code for FLAGEN TM FREE T4 is CEC.

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Other records listing Cyberfluor, 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.

K923410FIAGEN PROGESTERONEK905656FLAGEN TRIIODOTHYRONINE (T3) ASSAYK900621FIAGEN(TM) HLH.SK895186FIAGEN T3 UPTAKE CATALOGUE #101-402K895396CYBERFLUOR FIAGEN TSHK884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT

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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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