510(k) K100227

SAS FLUALERT A&B, SAS INFLUENZA A TEST by Sa Scientific, Inc. — Product Code PSZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 23, 2010
Date Received: January 26, 2010
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens
Device Class: Class II
Regulation Number: 866.3328
Review Panel: MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Other clearances by Sa Scientific, Inc.

K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST (August 22, 2013)
K080380 — SAS INFLUENZA A & B TEST (July 23, 2009)
K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (June 28, 2007)
K041441 — SAS INFLUENZA A TEST (July 22, 2004)
K041439 — SAS INFLUENZA B TEST (July 22, 2004)
K030628 — SAS RSV CONTROL KIT (March 17, 2003)
K022845 — SAS RSV TEST (January 29, 2003)
K022683 — SAS BLOOD/SERUM/URINE/URINE HCG (December 16, 2002)
K023270 — SAS STREPALERT (October 17, 2002)
K020438 — SAS VALUE HCG (March 8, 2002)

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