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510(k) K021541

NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT by Perkinelmer Life Sciences — Product Code JNB

K021541 is an FDA 510(k) premarket notification submitted by Perkinelmer Life Sciences for the device "NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT". The FDA issued a decision of Substantially Equivalent on October 28, 2002. 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. Perkinelmer Life Sciences has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2002
Date Received
May 10, 2002
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 Perkinelmer Life Sciences

  • DEN040002 — NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-89 (August 24, 2004)

Other clearances for product code JNB

  • K003584 — NEOLYNX SCREENING APPLICATION MANAGER (March 19, 2001)
  • 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