SAS ROTA TEST— 510(k) K990842

Substantially Equivalent

Sa Scientific, Inc.

FDA 510(k) clearance K990842 for SAS ROTA TEST, Substantially Equivalent on 1999-08-09. Applicant: Sa Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Sa Scientific, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1999-03-15
Decision date: 1999-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05
K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT1996-02-14

More clearances from Sa Scientific, Inc.

K100227 — SAS FLUALERT A&B, SAS INFLUENZA A TEST2010-02-23
K080380 — SAS INFLUENZA A & B TEST2009-07-23
K041439 — SAS INFLUENZA B TEST2004-07-22
K041441 — SAS INFLUENZA A TEST2004-07-22
K030628 — SAS RSV CONTROL KIT2003-03-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.