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510(k) K961954

SAS SALMONELLA H Z35 ANTISERUM by Sa Scientific, Inc. — Product Code GRM

K961954 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS SALMONELLA H Z35 ANTISERUM". The FDA issued a decision of Substantially Equivalent on June 18, 1996. The device falls under product code GRM (Antisera, 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
June 18, 1996
Date Received
May 20, 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

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 GRM

  • K961949 — SAS SALMONELLA O FACTOR 14 ANTISERUM (June 18, 1996)
  • K961951 — SAS SALMONELLA O FACTOR 6 ANTISERUM (June 18, 1996)
  • K961956 — SAS SALMONELLA H G,M,Q ANTISERMU (June 18, 1996)
  • K961961 — SAS SALMONELLA H F,G,T ANTISERUM (June 18, 1996)
  • K961953 — SAS SALMONELA H Z24 ANTISERUM (June 18, 1996)
  • K961958 — SAS SALMONELLA H Z4 COMPLEX ANTISERUM (June 18, 1996)
  • K961960 — SAS SALMONELLA H Z4, Z24 ANTISERUM (June 18, 1996)
  • K961964 — SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM (June 18, 1996)
  • K961963 — SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM (June 18, 1996)
  • K961957 — SAS SALMONELLA H Z4, Z32 ANTISERUM (June 18, 1996)

FDA data resources