FDA Product Code
FDA Product Code JNB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1555
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K021541 | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT | Perkinelmer Life Sciences | 2002-10-28 | Traditional | PDF ↗ |
| K003584 | NEOLYNX SCREENING APPLICATION MANAGER | Micromass, Inc. | 2001-03-19 | Traditional | PDF ↗ |
| K000754 | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 2000-06-19 | Traditional | PDF ↗ |
| K984463 | QUANTASE PHE/GAL SCREENING ASSAY | Quantase , Ltd. | 1999-02-16 | Traditional | PDF ↗ |
| K982307 | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | Wallac, Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K974047 | ACCUWELL PHENYLALANINE ASSAY | Neometrics, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K963040 | MANUAL PHENYLALANINE TEST | Bio-Rad | 1996-10-01 | Traditional | PDF ↗ |
| K960437 | RADIAS PHENYLALANINE TEST | Bio-Rad | 1996-08-16 | Traditional | PDF ↗ |
| K961515 | QUANTASE PHENYLALANINE ASSAY | Shield Diagnostics, Ltd. | 1996-06-12 | Traditional | PDF ↗ |
| K943547 | PHENYLALANINE TEST KIT | Isolab, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K926106 | IMMUCHEM PHE-MW EA | Icn Biomedicals, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K922547 | QUANTASE PHENYLALANINE ASSAY | Porton Cambridge , Ltd. | 1994-10-13 | Traditional | PDF ↗ |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Alpkem Corp. | 1989-10-27 | Traditional | PDF ↗ |
| K813449 | PHE/TYR KINETIC UV TEST SET | P-L Biochemicals, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K813171 | PHENYLALANINE UV KINETIC TEST KIT | Biochemicals, Inc. | 1981-12-03 | Traditional | PDF ↗ |
Product code JNB · Class II · Clinical Chemistry. Data: openFDA.