Cleared Traditional

FASTEP S10 HCG SERUM/URINE COMBO TEST

K132834 · Polymed Therapeutics, Inc. · Chemistry
Jan 2014
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K132834 is an FDA 510(k) clearance for the FASTEP S10 HCG SERUM/URINE COMBO TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Polymed Therapeutics, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 9, 2014, 121 days after receiving the submission on September 10, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K132834 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2013
Decision Date January 09, 2014
Days to Decision 121 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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