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510(k) K963040

MANUAL PHENYLALANINE TEST by Bio-Rad — Product Code JNB

K963040 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "MANUAL PHENYLALANINE TEST". The FDA issued a decision of Substantially Equivalent on October 1, 1996. 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. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1996
Date Received
August 5, 1996
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 Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

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)
  • 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)
  • 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