Cleared Traditional

MODIFICATION OF SAS SERUM/URINE HCG

K990684 · Sa Scientific, Inc. · Chemistry
May 1999
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K990684 is an FDA 510(k) clearance for the MODIFICATION OF SAS SERUM/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 May 10, 1999, 68 days after receiving the submission on March 3, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K990684 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1999
Decision Date May 10, 1999
Days to Decision 68 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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