FDA 510(k)

ONE-STEP PREGNANCY TEST

K-Number: K041273 · 2004-05-20

Decision Date2004-05-20

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ONE-STEP PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is W.H.P.M., Inc.. It received FDA 510(k) clearance on 2004-05-20 under 510(k) number K041273. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE-STEP PREGNANCY TEST?

ONE-STEP PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2004-05-20. The listed applicant is W.H.P.M., Inc.. The 510(k) number is K041273.

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

ONE-STEP PREGNANCY TEST received FDA 510(k) clearance on 2004-05-20, under 510(k) number K041273.

Who is the listed applicant for ONE-STEP PREGNANCY TEST?

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

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

The FDA product code for ONE-STEP PREGNANCY TEST is LCX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.