Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201

K-Number: K874621 · 1988-01-11

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

Device Summary

FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 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 K874621. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201?

FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 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 K874621.

When did FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 receive FDA 510(k) clearance?

FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 received FDA 510(k) clearance on 1988-01-11, under 510(k) number K874621.

Who is the listed applicant for FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201?

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) PROLACTIN CATALOGUE NUMBER: 102-201?

The FDA product code for FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 is CFT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, 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.

↑