Cleared Traditional

SAS ONE-STEP PREGNANCY

K964995 · Sa Scientific, Inc. · Chemistry
Jan 1997
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K964995 is an FDA 510(k) clearance for the SAS ONE-STEP PREGNANCY, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 21, 1997, 36 days after receiving the submission on December 16, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K964995 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1996
Decision Date January 21, 1997
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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