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510(k) K952135

SAS SALMONELLA H D ANTIGEN by Sa Scientific, Inc. — Product Code GSO

K952135 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS SALMONELLA H D ANTIGEN". The FDA issued a decision of Substantially Equivalent on July 17, 1995. The device falls under product code GSO (Antigens (Febrile), Agglutination, Brucella Spp.), a Class II device regulated under 21 CFR 866.3085. Sa Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1995
Date Received
May 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens (Febrile), Agglutination, Brucella Spp.
Device Class
Class II
Regulation Number
866.3085
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 GSO

  • K972396 — VISTA ANTIGEN BRUCELLA MELITENSIS (August 25, 1997)
  • K972394 — VISTA ANTIGEN BRUCELLA ABORTUS (August 25, 1997)
  • K952139 — SAS BRUCELLA SUIS ANTIGEN (July 18, 1995)
  • K952147 — SAS BRUCELLA ABORTUS ANTIGEN (July 17, 1995)
  • K952136 — SAS SALMONELLA H B ANTIGEN (July 17, 1995)
  • K952140 — SAS BRUCELLA MELTIENSIS ANTIGEN (July 17, 1995)
  • K952137 — SAS SALMONELLA H A ANTIGEN (July 17, 1995)
  • K952131 — SAS FEBRILE ANTIGEN SET (July 17, 1995)
  • K885112 — BRUCELLA IFA* (August 15, 1989)
  • K822663 — FEBRILE ANTIGEN KIT (September 21, 1982)

FDA data resources