Home / 510(k) Clearances / K090940

510(k) K090940

SPOTCHECK BLOOD SPOT CONTROL, ASSAYED by Astoria-Pacific, Inc. — Product Code JJT

K090940 is an FDA 510(k) premarket notification submitted by Astoria-Pacific, Inc. for the device "SPOTCHECK BLOOD SPOT CONTROL, ASSAYED". The FDA issued a decision of Substantially Equivalent on December 14, 2009. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Astoria-Pacific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2009
Date Received
April 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Astoria-Pacific, Inc.

  • K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (June 20, 2013)
  • K102643 — SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT (July 15, 2011)
  • K101392 — NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D (February 4, 2011)
  • K080294 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (November 4, 2008)
  • K010844 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (September 21, 2001)
  • K990957 — ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K (May 11, 1999)
  • K970093 — TYROSINE 50-HOUR REAGENT KIT (March 19, 1998)
  • K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (December 11, 1997)

Other clearances for product code JJT

  • K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (October 3, 2006)
  • K030768 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (March 21, 2003)
  • K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (January 24, 2003)
  • K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (May 24, 2002)
  • K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (September 6, 2001)
  • K993723 — CARDIASURE CARDIAC MARKERS CONTROL (November 23, 1999)
  • K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (November 16, 1999)
  • K992430 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (August 30, 1999)
  • K984437 — QUANTEX ASO-CRP-RP CONTROL II (February 2, 1999)
  • K984277 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (December 9, 1998)

FDA data resources