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510(k) K952143

SAS BRUCELLA MELITENSIS ANTISERUM by Sa Scientific, Inc. — Product Code GSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1995
Date Received
May 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Brucella Spp.
Device Class
Class II
Regulation Number
866.3085
Review Panel
MI
Submission Type

Other clearances by Sa Scientific, Inc.

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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 GSM

  • K952132 — SAS BRUCELLA AMS ANTISERUM (July 21, 1995)
  • K952146 — SAS BRUCELLAS ABORTUS ANTISERUM (July 21, 1995)
  • K952144 — SAS BRUCELLA SUIS ANTISERUM (July 21, 1995)