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FDA 510(k)

LUTEINIZING HORMONE (LH-IRMA) RIA KIT

K-Number: K864144 · 1986-11-24

ApplicantImmuchem Corp.
Decision Date1986-11-24
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUTEINIZING HORMONE (LH-IRMA) RIA 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 1986-11-24 under 510(k) number K864144. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUTEINIZING HORMONE (LH-IRMA) RIA KIT?

LUTEINIZING HORMONE (LH-IRMA) RIA KIT is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Immuchem Corp.. The 510(k) number is K864144.

When did LUTEINIZING HORMONE (LH-IRMA) RIA KIT receive FDA 510(k) clearance?

LUTEINIZING HORMONE (LH-IRMA) RIA KIT received FDA 510(k) clearance on 1986-11-24, under 510(k) number K864144.

Who is the listed applicant for LUTEINIZING HORMONE (LH-IRMA) RIA 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 LUTEINIZING HORMONE (LH-IRMA) RIA KIT?

The FDA product code for LUTEINIZING HORMONE (LH-IRMA) RIA KIT is CEP.

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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)K871542HPROLACTIN KITK865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITK860559ANDROSTENEDIONE 125I KIT BY RIAK854094IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS

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Related Devices (Code: CEP)

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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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