Cleared Traditional

SIGNAL PREGNANCY TEST KIT

K974021 · Sa Scientific, Inc. · Chemistry
Dec 1997
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K974021 is an FDA 510(k) clearance for the SIGNAL PREGNANCY TEST KIT, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 19, 1997, 58 days after receiving the submission on October 22, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K974021 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1997
Decision Date December 19, 1997
Days to Decision 58 days
Submission Type Traditional
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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