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510(k) K960461

SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM by Sa Scientific, Inc. — Product Code GRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
January 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Salmonella Spp.
Device Class
Class II
Regulation Number
866.3550
Review Panel
MI
Submission Type

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  • K080380 — SAS INFLUENZA A & B TEST (July 23, 2009)
  • K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (June 28, 2007)
  • K041439 — SAS INFLUENZA B TEST (July 22, 2004)
  • K041441 — SAS INFLUENZA A 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 GRM

  • K961966 — SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM (June 18, 1996)
  • K961962 — SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM (June 18, 1996)
  • K961958 — SAS SALMONELLA H Z4 COMPLEX ANTISERUM (June 18, 1996)
  • K961951 — SAS SALMONELLA O FACTOR 6 ANTISERUM (June 18, 1996)
  • K961964 — SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM (June 18, 1996)
  • K961952 — SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS (June 18, 1996)
  • K961954 — SAS SALMONELLA H Z35 ANTISERUM (June 18, 1996)
  • K961955 — SAS SALMONELLA H Z42 ANTISERUM (June 18, 1996)
  • K961963 — SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM (June 18, 1996)
  • K961953 — SAS SALMONELA H Z24 ANTISERUM (June 18, 1996)