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FDA 510(k)

BINAX PROLACTIN IRMA DIAGNOSTIC KIT

K-Number: K880218 · 1988-03-01

ApplicantBinax, Inc.
Decision Date1988-03-01
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BINAX PROLACTIN IRMA DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 1988-03-01 under 510(k) number K880218. 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 BINAX PROLACTIN IRMA DIAGNOSTIC KIT?

BINAX PROLACTIN IRMA DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1988-03-01. The listed applicant is Binax, Inc.. The 510(k) number is K880218.

When did BINAX PROLACTIN IRMA DIAGNOSTIC KIT receive FDA 510(k) clearance?

BINAX PROLACTIN IRMA DIAGNOSTIC KIT received FDA 510(k) clearance on 1988-03-01, under 510(k) number K880218.

Who is the listed applicant for BINAX PROLACTIN IRMA DIAGNOSTIC KIT?

The FDA 510(k) record lists Binax, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BINAX PROLACTIN IRMA DIAGNOSTIC KIT?

The FDA product code for BINAX PROLACTIN IRMA DIAGNOSTIC KIT is CFT.

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Other records listing Binax, Inc. as applicant

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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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