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FDA 510(k)

ANSWER OVULATION TEST KIT

K-Number: K871241 · 1987-10-02

ApplicantArmkel, LLC
Decision Date1987-10-02
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANSWER OVULATION TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1987-10-02 under 510(k) number K871241. 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 ANSWER OVULATION TEST KIT?

ANSWER OVULATION TEST KIT is a medical device that received FDA 510(k) clearance on 1987-10-02. The listed applicant is Armkel, LLC. The 510(k) number is K871241.

When did ANSWER OVULATION TEST KIT receive FDA 510(k) clearance?

ANSWER OVULATION TEST KIT received FDA 510(k) clearance on 1987-10-02, under 510(k) number K871241.

Who is the listed applicant for ANSWER OVULATION TEST KIT?

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

What is the FDA product code for ANSWER OVULATION TEST KIT?

The FDA product code for ANSWER OVULATION TEST KIT is CEP.

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Other records listing Armkel, LLC as applicant

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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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