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510(k) K990630

SAS ADENO TEST by Sa Scientific, Inc. — Product Code GOD

K990630 is an FDA 510(k) premarket notification submitted by Sa Scientific, Inc. for the device "SAS ADENO TEST". The FDA issued a decision of Substantially Equivalent on August 19, 1999. The device falls under product code GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33), a Class I device regulated under 21 CFR 866.3020. Sa Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1999
Date Received
February 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Device Class
Class I
Regulation Number
866.3020
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 GOD

  • K110722 — RPS ADENO DETECTOR PLUS (May 17, 2011)
  • K052092 — RPS ADENO DETECTOR (November 22, 2005)
  • K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (December 22, 1997)
  • K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (July 8, 1988)
  • K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (June 26, 1987)
  • K864645 — ADENOLEX (R) LATEX AGGLUTINATION TEST (June 4, 1987)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K802929 — ADENO VIRUS & CONTROLS (December 31, 1980)

FDA data resources