Cleared Traditional

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

K051841 · W.H.P.M., Inc. · Chemistry
Aug 2005
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K051841 is an FDA 510(k) clearance for the WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on August 22, 2005, 46 days after receiving the submission on July 7, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K051841 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2005
Decision Date August 22, 2005
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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