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510(k) K952145

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

K952145 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM". The FDA issued a decision of Substantially Equivalent on July 18, 1995. The device falls under product code GSN (Antiserum, Positive And Negative Febrile Antigen Control Serum), a Class II device regulated under 21 CFR 866.3085. Sa Scientific, Inc. has at least 10 other 510(k) clearances on record.

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

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 GSN

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

FDA data resources