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510(k) K970093

TYROSINE 50-HOUR REAGENT KIT by Astoria-Pacific, Inc. — Product Code CDR

K970093 is an FDA 510(k) premarket notification submitted by Astoria-Pacific, Inc. for the device "TYROSINE 50-HOUR REAGENT KIT". The FDA issued a decision of Substantially Equivalent on March 19, 1998. The device falls under product code CDR (1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine), a Class I device regulated under 21 CFR 862.1730. Astoria-Pacific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1998
Date Received
January 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
Device Class
Class I
Regulation Number
862.1730
Review Panel
CH
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)
  • K990957 — ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K (May 11, 1999)
  • K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (December 11, 1997)

FDA data resources