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FDA 510(k)

INVERNESS MEDICAL OVULATION PREDICTOR TEST

K-Number: K002867 · 2000-10-12

ApplicantSelfcare, Inc.
Decision Date2000-10-12
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INVERNESS MEDICAL OVULATION PREDICTOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Selfcare, Inc.. It received FDA 510(k) clearance on 2000-10-12 under 510(k) number K002867. 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 INVERNESS MEDICAL OVULATION PREDICTOR TEST?

INVERNESS MEDICAL OVULATION PREDICTOR TEST is a medical device that received FDA 510(k) clearance on 2000-10-12. The listed applicant is Selfcare, Inc.. The 510(k) number is K002867.

When did INVERNESS MEDICAL OVULATION PREDICTOR TEST receive FDA 510(k) clearance?

INVERNESS MEDICAL OVULATION PREDICTOR TEST received FDA 510(k) clearance on 2000-10-12, under 510(k) number K002867.

Who is the listed applicant for INVERNESS MEDICAL OVULATION PREDICTOR TEST?

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 INVERNESS MEDICAL OVULATION PREDICTOR TEST?

The FDA product code for INVERNESS MEDICAL 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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