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510(k) K013379

SAS STREPALERT by Sa Scientific, Inc. — Product Code GTY

K013379 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS STREPALERT". The FDA issued a decision of Substantially Equivalent on December 12, 2001. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Sa Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2001
Date Received
October 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by Sa Scientific, Inc.

  • K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST (August 22, 2013)
  • K100227 — SAS FLUALERT A&B, SAS INFLUENZA A TEST (February 23, 2010)
  • 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)

Other clearances for product code GTY

  • K260342 — AllTest Strep A Rapid Test (April 30, 2026)
  • K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test St (November 26, 2025)
  • K212623 — Healgen Strep A Rapid Test Strip (Throat Swab) (March 16, 2022)
  • K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer (December 21, 2017)
  • K141775 — SOFIA (R) STREP A+ FIA (December 16, 2014)
  • K133343 — WONDFO RAPID STREP A TEST (January 31, 2014)
  • K123793 — SOFIA STREP A FIA (June 17, 2013)
  • K122718 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (February 6, 2013)
  • K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
  • K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)

FDA data resources