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510(k) K984463

QUANTASE PHE/GAL SCREENING ASSAY by Quantase , Ltd. — Product Code JNB

K984463 is an FDA 510(k) premarket notification submitted by Quantase , Ltd. for the device "QUANTASE PHE/GAL SCREENING ASSAY". The FDA issued a decision of Substantially Equivalent on February 16, 1999. The device falls under product code JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine), a Class II device regulated under 21 CFR 862.1555. Quantase , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1999
Date Received
December 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Device Class
Class II
Regulation Number
862.1555
Review Panel
CH
Submission Type

Other clearances by Quantase , Ltd.

  • K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (June 19, 2000)
  • K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (June 21, 1999)
  • K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY (June 21, 1999)

Other clearances for product code JNB

  • K021541 — NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (October 28, 2002)
  • K003584 — NEOLYNX SCREENING APPLICATION MANAGER (March 19, 2001)
  • K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (June 19, 2000)
  • K982307 — WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (February 2, 1999)
  • K974047 — ACCUWELL PHENYLALANINE ASSAY (December 5, 1997)
  • K963040 — MANUAL PHENYLALANINE TEST (October 1, 1996)
  • K960437 — RADIAS PHENYLALANINE TEST (August 16, 1996)
  • K961515 — QUANTASE PHENYLALANINE ASSAY (June 12, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)
  • K926106 — IMMUCHEM PHE-MW EA (February 8, 1995)

FDA data resources