Cleared Traditional

SUREVUE URINE HCG

K010522 · Sa Scientific, Inc. · Toxicology
Jul 2001
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K010522 is an FDA 510(k) clearance for the SUREVUE URINE 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 July 31, 2001, 159 days after receiving the submission on February 22, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K010522 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2001
Decision Date July 31, 2001
Days to Decision 159 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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