FDA 510(k)

WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST

K-Number: K051841 · 2005-08-22

Decision Date2005-08-22

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

WH ACCU TEST ONE-STEP URINE/SERUM COMBO 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 2005-08-22 under 510(k) number K051841. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST?

WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2005-08-22. The listed applicant is W.H.P.M., Inc.. The 510(k) number is K051841.

When did WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST receive FDA 510(k) clearance?

WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST received FDA 510(k) clearance on 2005-08-22, under 510(k) number K051841.

Who is the listed applicant for WH ACCU TEST ONE-STEP URINE/SERUM COMBO 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 WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST?

The FDA product code for WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST is JHI.

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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.