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FDA 510(k)

CYBERFLUOR FIAGEN TSH

K-Number: K895396 · 1989-10-31

ApplicantCyberfluor, Inc.
Decision Date1989-10-31
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYBERFLUOR FIAGEN TSH is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K895396. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYBERFLUOR FIAGEN TSH?

CYBERFLUOR FIAGEN TSH is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K895396.

When did CYBERFLUOR FIAGEN TSH receive FDA 510(k) clearance?

CYBERFLUOR FIAGEN TSH received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895396.

Who is the listed applicant for CYBERFLUOR FIAGEN TSH?

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 CYBERFLUOR FIAGEN TSH?

The FDA product code for CYBERFLUOR FIAGEN TSH is JLW.

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Other records listing Cyberfluor, Inc. as applicant

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K923410FIAGEN PROGESTERONEK905656FLAGEN TRIIODOTHYRONINE (T3) ASSAYK904539FLAGEN TM FREE T4K900621FIAGEN(TM) HLH.SK895186FIAGEN T3 UPTAKE CATALOGUE #101-402K884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT

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Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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