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FDA 510(k)

CLEARPLANE EASY OVULATION TEST

K-Number: K013874 · 2002-02-19

ApplicantUnipath , Ltd.
Decision Date2002-02-19
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLEARPLANE EASY OVULATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 2002-02-19 under 510(k) number K013874. 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 CLEARPLANE EASY OVULATION TEST?

CLEARPLANE EASY OVULATION TEST is a medical device that received FDA 510(k) clearance on 2002-02-19. The listed applicant is Unipath , Ltd.. The 510(k) number is K013874.

When did CLEARPLANE EASY OVULATION TEST receive FDA 510(k) clearance?

CLEARPLANE EASY OVULATION TEST received FDA 510(k) clearance on 2002-02-19, under 510(k) number K013874.

Who is the listed applicant for CLEARPLANE EASY OVULATION TEST?

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

What is the FDA product code for CLEARPLANE EASY OVULATION TEST?

The FDA product code for CLEARPLANE EASY 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.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.K010244SURE CHECK OVULATION PREDICTORChembio Diagnostic Systems, 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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