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FDA 510(k)

HPROLACTIN KIT

K-Number: K871542 · 1987-05-14

ApplicantImmuchem Corp.
Decision Date1987-05-14
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HPROLACTIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1987-05-14 under 510(k) number K871542. 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 HPROLACTIN KIT?

HPROLACTIN KIT is a medical device that received FDA 510(k) clearance on 1987-05-14. The listed applicant is Immuchem Corp.. The 510(k) number is K871542.

When did HPROLACTIN KIT receive FDA 510(k) clearance?

HPROLACTIN KIT received FDA 510(k) clearance on 1987-05-14, under 510(k) number K871542.

Who is the listed applicant for HPROLACTIN KIT?

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

What is the FDA product code for HPROLACTIN KIT?

The FDA product code for HPROLACTIN KIT is CFT.

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Other records listing Immuchem 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.

K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALK871317FOLLICLE STIMULATING HORMONE (HFSH)K865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITK864144LUTEINIZING HORMONE (LH-IRMA) RIA KITK860559ANDROSTENEDIONE 125I KIT BY RIAK854094IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS

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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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