JNB — Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine Class II
FDA Device Classification
Classification Details
- Product Code
- JNB
- Device Class
- Class II
- Regulation Number
- 862.1555
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K021541 | perkinelmer life sciences | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT | October 28, 2002 |
| K003584 | micromass | NEOLYNX SCREENING APPLICATION MANAGER | March 19, 2001 |
| K000754 | quantase | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT | June 19, 2000 |
| K984463 | quantase | QUANTASE PHE/GAL SCREENING ASSAY | February 16, 1999 |
| K982307 | wallac | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | February 2, 1999 |
| K974047 | neometrics | ACCUWELL PHENYLALANINE ASSAY | December 5, 1997 |
| K963040 | bio-rad | MANUAL PHENYLALANINE TEST | October 1, 1996 |
| K960437 | bio-rad | RADIAS PHENYLALANINE TEST | August 16, 1996 |
| K961515 | shield diagnostics | QUANTASE PHENYLALANINE ASSAY | June 12, 1996 |
| K943547 | isolab | PHENYLALANINE TEST KIT | January 26, 1996 |
| K926106 | icn biomedicals | IMMUCHEM PHE-MW EA | February 8, 1995 |
| K922547 | porton cambridge | QUANTASE PHENYLALANINE ASSAY | October 13, 1994 |
| K891070 | alpkem | PHENYLALANINE (NINHYDRIN REACTION) | October 27, 1989 |
| K813449 | p-l biochemicals | PHE/TYR KINETIC UV TEST SET | December 31, 1981 |
| K813171 | biochemicals | PHENYLALANINE UV KINETIC TEST KIT | December 3, 1981 |