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FDA 510(k)

FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)

K-Number: K972720 · 1997-09-02

ApplicantMonobind
Decision Date1997-09-02
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1997-09-02 under 510(k) number K972720. 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 (FSH) MICROPLATE ELISA (425-300)?

FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) is a medical device that received FDA 510(k) clearance on 1997-09-02. The listed applicant is Monobind. The 510(k) number is K972720.

When did FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) receive FDA 510(k) clearance?

FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) received FDA 510(k) clearance on 1997-09-02, under 510(k) number K972720.

Who is the listed applicant for FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)?

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

What is the FDA product code for FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)?

The FDA product code for FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) is CGJ.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAK971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971921PROLACTIN (PRL) HORMONE MICROPLATE ELISA

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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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