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510(k) K102643

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT by Astoria-Pacific, Inc. — Product Code KQP

K102643 is an FDA 510(k) premarket notification submitted by Astoria-Pacific, Inc. for the device "SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT". The FDA issued a decision of Substantially Equivalent on July 15, 2011. The device falls under product code KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase), a Class II device regulated under 21 CFR 862.1315. Astoria-Pacific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2011
Date Received
September 14, 2010
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

Other clearances by Astoria-Pacific, Inc.

  • K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (June 20, 2013)
  • 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)
  • 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 KQP

  • 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)
  • K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (December 11, 1997)
  • K894011 — TOTAL GALACTOSE (January 11, 1990)

FDA data resources