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FDA 510(k)

LUTEINIZING HORMONE-EIA-XT

K-Number: K896866 · 1990-02-13

ApplicantIn Vitro Diagnostics, Inc.
Decision Date1990-02-13
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUTEINIZING HORMONE-EIA-XT is the device name listed in this FDA 510(k) record. The listed applicant is In Vitro Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-02-13 under 510(k) number K896866. 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-EIA-XT?

LUTEINIZING HORMONE-EIA-XT is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is In Vitro Diagnostics, Inc.. The 510(k) number is K896866.

When did LUTEINIZING HORMONE-EIA-XT receive FDA 510(k) clearance?

LUTEINIZING HORMONE-EIA-XT received FDA 510(k) clearance on 1990-02-13, under 510(k) number K896866.

Who is the listed applicant for LUTEINIZING HORMONE-EIA-XT?

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

What is the FDA product code for LUTEINIZING HORMONE-EIA-XT?

The FDA product code for LUTEINIZING HORMONE-EIA-XT is CEP.

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Other records listing In Vitro Diagnostics, 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.

K896867THYROID STIMULATING HORMONE-EIA-XTK896863DIGOXIN-EIA-XTK896865VITRO T4-EIA-XTK896925T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KITK896864FOLLICLE STIMULATING HORMONE-EIA-XTK873832REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801

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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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