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510(k) K010844

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K by Astoria-Pacific, Inc. — Product Code NAK

K010844 is an FDA 510(k) premarket notification submitted by Astoria-Pacific, Inc. for the device "ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K". The FDA issued a decision of Substantially Equivalent on September 21, 2001. The device falls under product code NAK (System, Test, Biotinidase), a Class II device regulated under 21 CFR 862.1118. Astoria-Pacific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2001
Date Received
March 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Biotinidase
Device Class
Class II
Regulation Number
862.1118
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)
  • K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (December 14, 2009)
  • K080294 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (November 4, 2008)
  • 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 NAK

  • K131284 — GSP NEONATAL BIOTINIDASE KIT (November 14, 2013)
  • K090123 — NEONATAL BIOTINIDASE KIT, MODEL 3018 (March 5, 2010)
  • K080294 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (November 4, 2008)
  • DEN990008 — WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 (February 15, 2000)

FDA data resources