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510(k) K003584

NEOLYNX SCREENING APPLICATION MANAGER by Micromass, Inc. — Product Code JNB

K003584 is an FDA 510(k) premarket notification submitted by Micromass, Inc. for the device "NEOLYNX SCREENING APPLICATION MANAGER". The FDA issued a decision of Substantially Equivalent on March 19, 2001. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2001
Date Received
November 20, 2000
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 for product code JNB

  • K021541 — NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (October 28, 2002)
  • K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (June 19, 2000)
  • K984463 — QUANTASE PHE/GAL SCREENING ASSAY (February 16, 1999)
  • 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