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510(k) K970277

URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) by Astoria-Pacific, Inc. — Product Code KQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1997
Date Received
January 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Device Class
Class II
Regulation Number
862.1315
Review Panel
CH
Submission Type

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  • K010844 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (September 21, 2001)
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Other clearances for product code KQP

  • 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)
  • K100101 — GSP NEONATALGALT KIT, MODEL 3303-001U (June 11, 2010)
  • K993536 — BIO-RAD CODA NEONATAL GALT ASSAY (November 4, 1999)
  • K990827 — MICROPLATE NEONATAL GALT ASSAY (April 9, 1999)
  • K894011 — TOTAL GALACTOSE (January 11, 1990)