Cleared Traditional

SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT

K010593 · Sa Scientific, Inc. · Chemistry
Apr 2001
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K010593 is an FDA 510(k) clearance for the SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT, 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 April 5, 2001, 36 days after receiving the submission on February 28, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K010593 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2001
Decision Date April 05, 2001
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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