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FDA 510(k)

EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)

K-Number: K991466 · 1999-05-25

ApplicantSelfcare, Inc.
Decision Date1999-05-25
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) is the device name listed in this FDA 510(k) record. The listed applicant is Selfcare, Inc.. It received FDA 510(k) clearance on 1999-05-25 under 510(k) number K991466. 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 EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)?

EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) is a medical device that received FDA 510(k) clearance on 1999-05-25. The listed applicant is Selfcare, Inc.. The 510(k) number is K991466.

When did EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) receive FDA 510(k) clearance?

EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) received FDA 510(k) clearance on 1999-05-25, under 510(k) number K991466.

Who is the listed applicant for EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)?

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

What is the FDA product code for EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)?

The FDA product code for EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) 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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