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FDA 510(k)

MICROCHECK LH OVULATION TEST

K-Number: K871602 · 1987-06-11

ApplicantSyntron Bioresearch, Inc.
Decision Date1987-06-11
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROCHECK LH OVULATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1987-06-11 under 510(k) number K871602. 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 MICROCHECK LH OVULATION TEST?

MICROCHECK LH OVULATION TEST is a medical device that received FDA 510(k) clearance on 1987-06-11. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K871602.

When did MICROCHECK LH OVULATION TEST receive FDA 510(k) clearance?

MICROCHECK LH OVULATION TEST received FDA 510(k) clearance on 1987-06-11, under 510(k) number K871602.

Who is the listed applicant for MICROCHECK LH OVULATION TEST?

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

What is the FDA product code for MICROCHECK LH OVULATION TEST?

The FDA product code for MICROCHECK LH OVULATION TEST is CEP.

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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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