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510(k) K990957

ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K by Astoria-Pacific, Inc. — Product Code JBL

K990957 is an FDA 510(k) premarket notification submitted by Astoria-Pacific, Inc. for the device "ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K". The FDA issued a decision of Substantially Equivalent on May 11, 1999. The device falls under product code JBL (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative), a Class II device regulated under 21 CFR 864.7360. Astoria-Pacific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1999
Date Received
March 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Device Class
Class II
Regulation Number
864.7360
Review Panel
HE
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)
  • K010844 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (September 21, 2001)
  • 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 JBL

  • K790211 — DEHYDROGENOSE, GLUCOSE PHOSPHATE (March 15, 1979)

FDA data resources