Cleared Traditional

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

K112101 · Polymed Therapeutics, Inc. · Chemistry
Jul 2012
Decision
361d
Days
Class 2
Risk

About This 510(k) Submission

K112101 is an FDA 510(k) clearance for the FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Polymed Therapeutics, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on July 17, 2012, 361 days after receiving the submission on July 22, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K112101 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2011
Decision Date July 17, 2012
Days to Decision 361 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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