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FDA 510(k)

FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301

K-Number: K874624 · 1988-01-11

ApplicantCyberfluor, Inc.
Decision Date1988-01-11
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1988-01-11 under 510(k) number K874624. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301?

FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 is a medical device that received FDA 510(k) clearance on 1988-01-11. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K874624.

When did FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 receive FDA 510(k) clearance?

FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 received FDA 510(k) clearance on 1988-01-11, under 510(k) number K874624.

Who is the listed applicant for FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301?

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) HLH CATALOGUE NUMBER: 102-301?

The FDA product code for FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 is CEP.

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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 #101-402K895396CYBERFLUOR FIAGEN TSH

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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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