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FDA 510(k)

BLHI LUTEINIZING HORMONE

K-Number: K851332 · 1985-07-09

ApplicantEuro-Diagnostics BV
Decision Date1985-07-09
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLHI LUTEINIZING HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Diagnostics BV. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K851332. 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 BLHI LUTEINIZING HORMONE?

BLHI LUTEINIZING HORMONE is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is Euro-Diagnostics BV. The 510(k) number is K851332.

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

BLHI LUTEINIZING HORMONE received FDA 510(k) clearance on 1985-07-09, under 510(k) number K851332.

Who is the listed applicant for BLHI LUTEINIZING HORMONE?

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

What is the FDA product code for BLHI LUTEINIZING HORMONE?

The FDA product code for BLHI LUTEINIZING HORMONE is CEP.

Related Clinical Trials

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.

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Other records listing Euro-Diagnostics BV 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.

K851148TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONEK850053BACI 6 -ADRENOCORTICOTROOP HORMONEK843930IRMA IMMUNORADIOMETRIC ASSAY-FSH 125IK842478PROLACTIN IRMA

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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