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FDA 510(k)

RADIOIMMUNOASSAY LUTEINIZING HORMONE

K-Number: K811994 · 1981-07-27

ApplicantEndocrine-Metabolic Center
Decision Date1981-07-27
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY LUTEINIZING HORMONE 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 1981-07-27 under 510(k) number K811994. 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 RADIOIMMUNOASSAY LUTEINIZING HORMONE?

RADIOIMMUNOASSAY LUTEINIZING HORMONE is a medical device that received FDA 510(k) clearance on 1981-07-27. The listed applicant is Endocrine-Metabolic Center. The 510(k) number is K811994.

When did RADIOIMMUNOASSAY LUTEINIZING HORMONE receive FDA 510(k) clearance?

RADIOIMMUNOASSAY LUTEINIZING HORMONE received FDA 510(k) clearance on 1981-07-27, under 510(k) number K811994.

Who is the listed applicant for RADIOIMMUNOASSAY LUTEINIZING HORMONE?

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 LUTEINIZING HORMONE?

The FDA product code for RADIOIMMUNOASSAY LUTEINIZING HORMONE is CEP.

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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 MIDK811993RADIOIMMUNOASSAY, FOLLICLE STIMULATINGK810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITK810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIEK800187EMC-M-175, THYROXINE - 100 TUBESK800188EMC-M-180, T3 UPTAKE - 100 TUBES

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Related Devices (Code: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, 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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