JNB — Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine Class II
FDA product code JNB covers "Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine", a Class II medical device regulated under 21 CFR 862.1555. Submissions are reviewed by the Clinical Chemistry panel. At least 15 recent 510(k) clearances have been granted under this product code.
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 |