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FDA 510(k)

DBEST ONE-STEP OVULATION TEST

K-Number: K974508 · 1998-02-02

ApplicantAmeritek, Inc.
Decision Date1998-02-02
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DBEST ONE-STEP OVULATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1998-02-02 under 510(k) number K974508. 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 DBEST ONE-STEP OVULATION TEST?

DBEST ONE-STEP OVULATION TEST is a medical device that received FDA 510(k) clearance on 1998-02-02. The listed applicant is Ameritek, Inc.. The 510(k) number is K974508.

When did DBEST ONE-STEP OVULATION TEST receive FDA 510(k) clearance?

DBEST ONE-STEP OVULATION TEST received FDA 510(k) clearance on 1998-02-02, under 510(k) number K974508.

Who is the listed applicant for DBEST ONE-STEP OVULATION TEST?

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

What is the FDA product code for DBEST ONE-STEP OVULATION TEST?

The FDA product code for DBEST ONE-STEP OVULATION TEST is 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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