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510(k) K955212

SAS SALMONELLA H FACTOR 5 ANTISERUM by Sa Scientific, Inc. — Product Code GNC

K955212 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS SALMONELLA H FACTOR 5 ANTISERUM". The FDA issued a decision of Substantially Equivalent on February 7, 1996. The device falls under product code GNC (Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.), a Class II device regulated under 21 CFR 866.3550. Sa Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1996
Date Received
November 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Device Class
Class II
Regulation Number
866.3550
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 GNC

  • K972387 — VISTA ANTIGEN SALMONELLA O GROUP A (August 25, 1997)
  • K972392 — VISTA ANTIGEN SALMONELLA H A (August 25, 1997)
  • K972390 — VISTA ANTIGEN SALMONELLA H C (August 25, 1997)
  • K972388 — VISTA ANTIGEN SALMONELLA O GROUP C (August 25, 1997)
  • K972386 — VISTA ANTIGEN SALMONELLA O GROUP B (August 25, 1997)
  • K972395 — VISTA ANTIGEN SALMONELLA O GROUP D (August 25, 1997)
  • K972389 — VISTA ANTIGEN SALMONELLA H D (August 25, 1997)
  • K972391 — VISTA ANTIGEN SALMONELLA H B (August 25, 1997)
  • K955225 — SAS SPICER-EDWARDS 3 ANTISERUM (February 13, 1996)
  • K955228 — SAS SPICER-EDWARDS L COMPLEX (February 13, 1996)

FDA data resources