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FDA 510(k)

RADIOIMMUNOASSAY, FOLLICLE STIMULATING

K-Number: K811993 · 1981-08-03

ApplicantEndocrine-Metabolic Center
Decision Date1981-08-03
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY, FOLLICLE STIMULATING is the device name listed in this FDA 510(k) record. The listed applicant is Endocrine-Metabolic Center. It received FDA 510(k) clearance on 1981-08-03 under 510(k) number K811993. 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 RADIOIMMUNOASSAY, FOLLICLE STIMULATING?

RADIOIMMUNOASSAY, FOLLICLE STIMULATING is a medical device that received FDA 510(k) clearance on 1981-08-03. The listed applicant is Endocrine-Metabolic Center. The 510(k) number is K811993.

When did RADIOIMMUNOASSAY, FOLLICLE STIMULATING receive FDA 510(k) clearance?

RADIOIMMUNOASSAY, FOLLICLE STIMULATING received FDA 510(k) clearance on 1981-08-03, under 510(k) number K811993.

Who is the listed applicant for RADIOIMMUNOASSAY, FOLLICLE STIMULATING?

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

What is the FDA product code for RADIOIMMUNOASSAY, FOLLICLE STIMULATING?

The FDA product code for RADIOIMMUNOASSAY, FOLLICLE STIMULATING is CGJ.

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Other records listing Endocrine-Metabolic Center 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.

K821131RADIOIMMUNOASSAY PARATHYROID HORMONE MIDK811994RADIOIMMUNOASSAY LUTEINIZING HORMONEK810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITK810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIEK800187EMC-M-175, THYROXINE - 100 TUBESK800188EMC-M-180, T3 UPTAKE - 100 TUBES

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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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