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FDA 510(k)

TBD* ONE-STEP OVULATION PREDICTOR TEST

K-Number: K973310 · 1997-10-27

ApplicantArmkel, LLC
Decision Date1997-10-27
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TBD* ONE-STEP 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 1997-10-27 under 510(k) number K973310. 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 TBD* ONE-STEP OVULATION PREDICTOR TEST?

TBD* ONE-STEP OVULATION PREDICTOR TEST is a medical device that received FDA 510(k) clearance on 1997-10-27. The listed applicant is Armkel, LLC. The 510(k) number is K973310.

When did TBD* ONE-STEP OVULATION PREDICTOR TEST receive FDA 510(k) clearance?

TBD* ONE-STEP OVULATION PREDICTOR TEST received FDA 510(k) clearance on 1997-10-27, under 510(k) number K973310.

Who is the listed applicant for TBD* ONE-STEP 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 TBD* ONE-STEP OVULATION PREDICTOR TEST?

The FDA product code for TBD* ONE-STEP OVULATION PREDICTOR TEST is CEP.

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Related Devices (Code: CEP)

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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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