Cleared Traditional

SAS ROTA TEST

K990842 · Sa Scientific, Inc. · Microbiology
Aug 1999
Decision
147d
Days
Class 1
Risk

About This 510(k) Submission

K990842 is an FDA 510(k) clearance for the SAS ROTA TEST, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 9, 1999, 147 days after receiving the submission on March 15, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K990842 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1999
Decision Date August 09, 1999
Days to Decision 147 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405

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