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FDA 510(k)

FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101

K-Number: K874623 · 1988-02-16

ApplicantCyberfluor, Inc.
Decision Date1988-02-16
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1988-02-16 under 510(k) number K874623. 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 FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101?

FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 is a medical device that received FDA 510(k) clearance on 1988-02-16. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K874623.

When did FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 receive FDA 510(k) clearance?

FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 received FDA 510(k) clearance on 1988-02-16, under 510(k) number K874623.

Who is the listed applicant for FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101?

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 FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101?

The FDA product code for FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 is CDX.

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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) ASSAYK904539FLAGEN TM FREE T4K900621FIAGEN(TM) HLH.SK895186FIAGEN T3 UPTAKE CATALOGUE #101-402K895396CYBERFLUOR FIAGEN TSH

View all 17 devices →

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.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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