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FDA 510(k)

PROLACTIN (125) RADIOIMMUNAOASSAY

K-Number: K803273 · 1981-01-16

ApplicantCorning Medical & Scientific
Decision Date1981-01-16
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN (125) RADIOIMMUNAOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803273. 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 PROLACTIN (125) RADIOIMMUNAOASSAY?

PROLACTIN (125) RADIOIMMUNAOASSAY is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Corning Medical & Scientific. The 510(k) number is K803273.

When did PROLACTIN (125) RADIOIMMUNAOASSAY receive FDA 510(k) clearance?

PROLACTIN (125) RADIOIMMUNAOASSAY received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803273.

Who is the listed applicant for PROLACTIN (125) RADIOIMMUNAOASSAY?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROLACTIN (125) RADIOIMMUNAOASSAY?

The FDA product code for PROLACTIN (125) RADIOIMMUNAOASSAY is CFT.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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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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