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FDA 510(k)

FIRST RESPONSE OVULATION PREDICTOR TEST

K-Number: K953581 · 1995-10-03

ApplicantArmkel, LLC
Decision Date1995-10-03
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIRST RESPONSE OVULATION PREDICTOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1995-10-03 under 510(k) number K953581. 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 FIRST RESPONSE OVULATION PREDICTOR TEST?

FIRST RESPONSE OVULATION PREDICTOR TEST is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is Armkel, LLC. The 510(k) number is K953581.

When did FIRST RESPONSE OVULATION PREDICTOR TEST receive FDA 510(k) clearance?

FIRST RESPONSE OVULATION PREDICTOR TEST received FDA 510(k) clearance on 1995-10-03, under 510(k) number K953581.

Who is the listed applicant for FIRST RESPONSE OVULATION PREDICTOR TEST?

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 FIRST RESPONSE OVULATION PREDICTOR TEST?

The FDA product code for FIRST RESPONSE OVULATION PREDICTOR 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.

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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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