Cleared Traditional

SAS RSV CONTROL KIT

K030628 · Sa Scientific, Inc. · Chemistry
Mar 2003
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K030628 is an FDA 510(k) clearance for the SAS RSV CONTROL KIT, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 17, 2003, 18 days after receiving the submission on February 27, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K030628 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2003
Decision Date March 17, 2003
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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