Cleared Traditional

SAS HCG URINE CONTROLS

K990755 · Sa Scientific, Inc. · Chemistry
Mar 1999
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K990755 is an FDA 510(k) clearance for the SAS HCG URINE CONTROLS, 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 19, 1999, 11 days after receiving the submission on March 8, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K990755 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1999
Decision Date March 19, 1999
Days to Decision 11 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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