Cleared Special

AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015

K993141 · Phamatech · Chemistry
Nov 1999
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K993141 is an FDA 510(k) clearance for the AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on November 8, 1999, 48 days after receiving the submission on September 21, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K993141 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1999
Decision Date November 08, 1999
Days to Decision 48 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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