Cleared Abbreviated

SAS VALUE HCG

K020438 · Sa Scientific, Inc. · Chemistry
Mar 2002
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K020438 is an FDA 510(k) clearance for the SAS VALUE HCG, 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 March 8, 2002, 25 days after receiving the submission on February 11, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K020438 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2002
Decision Date March 08, 2002
Days to Decision 25 days
Submission Type Abbreviated
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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