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FDA 510(k)

FLAGEN TRIIODOTHYRONINE (T3) ASSAY

K-Number: K905656 · 1991-01-23

ApplicantCyberfluor, Inc.
Decision Date1991-01-23
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLAGEN TRIIODOTHYRONINE (T3) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1991-01-23 under 510(k) number K905656. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLAGEN TRIIODOTHYRONINE (T3) ASSAY?

FLAGEN TRIIODOTHYRONINE (T3) ASSAY is a medical device that received FDA 510(k) clearance on 1991-01-23. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K905656.

When did FLAGEN TRIIODOTHYRONINE (T3) ASSAY receive FDA 510(k) clearance?

FLAGEN TRIIODOTHYRONINE (T3) ASSAY received FDA 510(k) clearance on 1991-01-23, under 510(k) number K905656.

Who is the listed applicant for FLAGEN TRIIODOTHYRONINE (T3) ASSAY?

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 TRIIODOTHYRONINE (T3) ASSAY?

The FDA product code for FLAGEN TRIIODOTHYRONINE (T3) ASSAY is CDP.

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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 PROGESTERONEK904539FLAGEN TM FREE T4K900621FIAGEN(TM) HLH.SK895186FIAGEN T3 UPTAKE CATALOGUE #101-402K895396CYBERFLUOR FIAGEN TSHK884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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