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510(k) K961558

SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM by Sa Scientific, Inc. — Product Code GNB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1996
Date Received
April 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Shigella Spp.
Device Class
Class II
Regulation Number
866.3660
Review Panel
MI
Submission Type

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  • 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 GNB

  • K961537 — SAS SHIGELLA SONNEI FORM II ANTISERUM (May 31, 1996)
  • K961556 — SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM (May 20, 1996)
  • K961546 — SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM (May 20, 1996)
  • K961531 — SAS SHIGELLA BOYDII TYPE 13 ANTISERUM (May 20, 1996)
  • K961559 — SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM (May 20, 1996)
  • K961538 — SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM (May 20, 1996)
  • K961541 — SAS SHIGELLA BOYDII TYPE 8 ANTISERUM (May 20, 1996)
  • K961535 — SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM (May 20, 1996)
  • K961549 — SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM (May 20, 1996)
  • K961551 — SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM (May 20, 1996)