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FDA 510(k)

FOLLICLE STIMULATING HORMONE (HFSH)

K-Number: K871317 · 1987-05-20

ApplicantImmuchem Corp.
Decision Date1987-05-20
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FOLLICLE STIMULATING HORMONE (HFSH) is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1987-05-20 under 510(k) number K871317. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOLLICLE STIMULATING HORMONE (HFSH)?

FOLLICLE STIMULATING HORMONE (HFSH) is a medical device that received FDA 510(k) clearance on 1987-05-20. The listed applicant is Immuchem Corp.. The 510(k) number is K871317.

When did FOLLICLE STIMULATING HORMONE (HFSH) receive FDA 510(k) clearance?

FOLLICLE STIMULATING HORMONE (HFSH) received FDA 510(k) clearance on 1987-05-20, under 510(k) number K871317.

Who is the listed applicant for FOLLICLE STIMULATING HORMONE (HFSH)?

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 FOLLICLE STIMULATING HORMONE (HFSH)?

The FDA product code for FOLLICLE STIMULATING HORMONE (HFSH) is CGJ.

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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 NEONATALK871542HPROLACTIN KITK865071THYROID 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: CGJ)

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.

K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, 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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