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FDA 510(k)

LUTEINIZING HORMONE (LH) RIA

K-Number: K792000 · 1979-10-30

ApplicantCis Radiopharmaceuticals, Inc.
Decision Date1979-10-30
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUTEINIZING HORMONE (LH) RIA is the device name listed in this FDA 510(k) record. The listed applicant is Cis Radiopharmaceuticals, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K792000. 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 LUTEINIZING HORMONE (LH) RIA?

LUTEINIZING HORMONE (LH) RIA is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Cis Radiopharmaceuticals, Inc.. The 510(k) number is K792000.

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

LUTEINIZING HORMONE (LH) RIA received FDA 510(k) clearance on 1979-10-30, under 510(k) number K792000.

Who is the listed applicant for LUTEINIZING HORMONE (LH) RIA?

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

What is the FDA product code for LUTEINIZING HORMONE (LH) RIA?

The FDA product code for LUTEINIZING HORMONE (LH) RIA is CEP.

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Other records listing Cis Radiopharmaceuticals, Inc. 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.

K791860FERRITIN RIA KITK792063FOLLICLE STIMULATING HORMONE (FSH) KITK791202RIA KIT FOR TRYPSINK791051PROGESTERONE RADIOIMMUNOASSAY KITK790003RIA KIT, PROLACTINK780982KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT

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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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