Panels › Clinical Chemistry › Product code JNB · Class 2
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Regulation 862.1555
0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JNB
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 2 | 0 |
| Quantase , Ltd. | 2 | 0 |
| Alpkem Corp. | 1 | 0 |
| Bio-Rad Laboratories Inc | 0 | 1 |
| Biochemicals, Inc. | 1 | 0 |
| Icn Biomedicals, Inc. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Micromass, Inc. | 1 | 0 |
| Neometrics, Inc. | 1 | 0 |
| P-L Biochemicals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2002 | K021541 | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT Perkinelmer Life Sciences | JNB |
| Mar 19, 2001 | K003584 | NEOLYNX SCREENING APPLICATION MANAGER Micromass, Inc. | JNB |
| Jun 19, 2000 | K000754 | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT Quantase , Ltd., GB | JNB |
| Feb 16, 1999 | K984463 | QUANTASE PHE/GAL SCREENING ASSAY Quantase , Ltd., GB | JNB |
| Feb 2, 1999 | K982307 | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 Wallac, Inc. | JNB |
| Dec 5, 1997 | K974047 | ACCUWELL PHENYLALANINE ASSAY Neometrics, Inc. | JNB |
| Oct 1, 1996 | K963040 | MANUAL PHENYLALANINE TEST Bio-Rad | JNB |
| Aug 16, 1996 | K960437 | RADIAS PHENYLALANINE TEST Bio-Rad | JNB |
| Jun 12, 1996 | K961515 | QUANTASE PHENYLALANINE ASSAY Shield Diagnostics, Ltd., GB | JNB |
| Jan 26, 1996 | K943547 | PHENYLALANINE TEST KIT Isolab, Inc. | JNB |
| Feb 8, 1995 | K926106 | IMMUCHEM PHE-MW EA Icn Biomedicals, Inc. | JNB |
| Oct 13, 1994 | K922547 | QUANTASE PHENYLALANINE ASSAY Porton Cambridge , Ltd., GB | JNB |
| Oct 27, 1989 | K891070 | PHENYLALANINE (NINHYDRIN REACTION) Alpkem Corp. | JNB |
| Dec 31, 1981 | K813449 | PHE/TYR KINETIC UV TEST SET P-L Biochemicals, Inc. | JNB |
| Dec 3, 1981 | K813171 | PHENYLALANINE UV KINETIC TEST KIT Biochemicals, Inc. | JNB |
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