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510(k) K121101

SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT by Astoria-Pacific, Inc. — Product Code JIA

K121101 is an FDA 510(k) premarket notification submitted by Astoria-Pacific, Inc. for the device "SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT". The FDA issued a decision of Substantially Equivalent on June 20, 2013. The device falls under product code JIA (Enzymatic Methods, Galactose), a Class I device regulated under 21 CFR 862.1310. Astoria-Pacific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2013
Date Received
April 11, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Methods, Galactose
Device Class
Class I
Regulation Number
862.1310
Review Panel
CH
Submission Type

Other clearances by Astoria-Pacific, Inc.

  • 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)
  • 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 JIA

  • K190335 — GSP Neonatal Total Galactose kit (November 6, 2019)
  • K133652 — GSP NEONATAL TOTAL GALACTOSE KIT (April 28, 2014)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (June 21, 1999)
  • K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY (June 21, 1999)
  • K991498 — ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (June 16, 1999)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 1996)
  • K951329 — IMMUCHEM GAL-MW EA (November 9, 1995)

FDA data resources