Product code JNB— Clinical Chemistry
QUANTASE PHENYLALANINE ASSAY
- Classification name
- Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- Device class
- Class 2
- Regulation
- 21 CFR 862.1555
- Advisory panel
- Clinical Chemistry
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code JNB
FDA has cleared devices under product code JNB between 1981 and 2002, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2002
- 2001
- 2000
- 1999
- 1997
- 1996
- 1995
- 1994
- 1989
- 1981
Top applicants under product code JNB
Recent clearances under product code JNB
- K021541 — NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
- K003584 — NEOLYNX SCREENING APPLICATION MANAGER
- K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
- K984463 — QUANTASE PHE/GAL SCREENING ASSAY
- K982307 — WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
- K974047 — ACCUWELL PHENYLALANINE ASSAY
- K963040 — MANUAL PHENYLALANINE TEST
- K960437 — RADIAS PHENYLALANINE TEST
- K961515 — QUANTASE PHENYLALANINE ASSAY
- K943547 — PHENYLALANINE TEST KIT
- K926106 — IMMUCHEM PHE-MW EA
- K922547 — QUANTASE PHENYLALANINE ASSAY
- K891070 — PHENYLALANINE (NINHYDRIN REACTION)
- K813449 — PHE/TYR KINETIC UV TEST SET
- K813171 — PHENYLALANINE UV KINETIC TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.