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FDA 510(k)

ELECSYS LH ASSAY

K-Number: K964694 · 1997-01-24

ApplicantBoehringer Mannheim Corp.
Decision Date1997-01-24
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS LH ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964694. 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 ELECSYS LH ASSAY?

ELECSYS LH ASSAY is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K964694.

When did ELECSYS LH ASSAY receive FDA 510(k) clearance?

ELECSYS LH ASSAY received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964694.

Who is the listed applicant for ELECSYS LH ASSAY?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS LH ASSAY?

The FDA product code for ELECSYS LH ASSAY is CEP.

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Other records listing Boehringer Mannheim Corp. 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.

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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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