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FDA 510(k)

CIBA CORNING ACS PROLACTIN IMMUNOASSAY

K-Number: K904714 · 1990-11-07

ApplicantCiba Corning Diagnostics Corp.
Decision Date1990-11-07
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS PROLACTIN IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1990-11-07 under 510(k) number K904714. 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 CIBA CORNING ACS PROLACTIN IMMUNOASSAY?

CIBA CORNING ACS PROLACTIN IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1990-11-07. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K904714.

When did CIBA CORNING ACS PROLACTIN IMMUNOASSAY receive FDA 510(k) clearance?

CIBA CORNING ACS PROLACTIN IMMUNOASSAY received FDA 510(k) clearance on 1990-11-07, under 510(k) number K904714.

Who is the listed applicant for CIBA CORNING ACS PROLACTIN IMMUNOASSAY?

The FDA 510(k) record lists Ciba Corning Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIBA CORNING ACS PROLACTIN IMMUNOASSAY?

The FDA product code for CIBA CORNING ACS PROLACTIN IMMUNOASSAY is CFT.

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Other records listing Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

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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.

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