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FDA 510(k)

FOLLICLE-STIMULATING HORMONE

K-Number: K771756 · 1977-10-18

ApplicantNichols Institute Diagnostics
Decision Date1977-10-18
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FOLLICLE-STIMULATING HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K771756. 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?

FOLLICLE-STIMULATING HORMONE is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K771756.

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

FOLLICLE-STIMULATING HORMONE received FDA 510(k) clearance on 1977-10-18, under 510(k) number K771756.

Who is the listed applicant for FOLLICLE-STIMULATING HORMONE?

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

What is the FDA product code for FOLLICLE-STIMULATING HORMONE?

The FDA product code for FOLLICLE-STIMULATING HORMONE is CGJ.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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