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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

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

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  • K970093 — TYROSINE 50-HOUR REAGENT KIT (March 19, 1998)
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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)