Cleared Traditional

WH ACCU TEST PREGNANCY TEST

K012284 · W.H.P.M., Inc. · Chemistry
Aug 2001
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K012284 is an FDA 510(k) clearance for the WH ACCU TEST 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 28, 2001, 39 days after receiving the submission on July 20, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K012284 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2001
Decision Date August 28, 2001
Days to Decision 39 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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