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FDA 510(k)

FIAGEN PROGESTERONE

K-Number: K923410 · 1992-12-03

ApplicantCyberfluor, Inc.
Decision Date1992-12-03
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIAGEN PROGESTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1992-12-03 under 510(k) number K923410. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAGEN PROGESTERONE?

FIAGEN PROGESTERONE is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K923410.

When did FIAGEN PROGESTERONE receive FDA 510(k) clearance?

FIAGEN PROGESTERONE received FDA 510(k) clearance on 1992-12-03, under 510(k) number K923410.

Who is the listed applicant for FIAGEN PROGESTERONE?

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 PROGESTERONE?

The FDA product code for FIAGEN PROGESTERONE is JLS.

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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.

K905656FLAGEN TRIIODOTHYRONINE (T3) ASSAYK904539FLAGEN 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: JLS)

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.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, 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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