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510(k) K952141

SAS FRANCISELLA TULARENSIS ANTISERUM by Sa Scientific, Inc. — Product Code GSK

K952141 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS FRANCISELLA TULARENSIS ANTISERUM". The FDA issued a decision of Substantially Equivalent on July 21, 1995. The device falls under product code GSK (Antiserum, Francisella Tularensis), a Class II device regulated under 21 CFR 866.3280. Sa Scientific, Inc. has at least 10 other 510(k) clearances on record.

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
Antiserum, Francisella Tularensis
Device Class
Class II
Regulation Number
866.3280
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)

FDA data resources