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510(k) K952145

SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM by Sa Scientific, Inc. — Product Code GSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1995
Date Received
May 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Positive And Negative Febrile Antigen Control Serum
Device Class
Class II
Regulation Number
866.3085
Review Panel
MI
Submission Type

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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 GSN

  • K885113 — IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL (August 15, 1989)
  • K791385 — NEGATIVE CONTROL SERUM FOR CF RO ID (August 16, 1979)