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510(k) K961551

SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM by Sa Scientific, Inc. — Product Code GNB

K961551 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM". The FDA issued a decision of Substantially Equivalent on May 20, 1996. The device falls under product code GNB (Antisera, All Types, Shigella Spp.), a Class II device regulated under 21 CFR 866.3660. Sa Scientific, Inc. has at least 10 other 510(k) clearances on record.

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

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 GNB

  • K961537 — SAS SHIGELLA SONNEI FORM II ANTISERUM (May 31, 1996)
  • K961541 — SAS SHIGELLA BOYDII TYPE 8 ANTISERUM (May 20, 1996)
  • K961546 — SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM (May 20, 1996)
  • K961539 — SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM (May 20, 1996)
  • K961540 — SAS SHIGELLA SONNEI GROUP D ANTISERUM (May 20, 1996)
  • K961534 — SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) (May 20, 1996)
  • K961556 — SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM (May 20, 1996)
  • K961553 — SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM (May 20, 1996)
  • K961547 — SAS SHIGELLA BOYDII TYPE 14 ANTISERUM (May 20, 1996)
  • K961533 — SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM (May 20, 1996)

FDA data resources