510(k) K960437
- Device
- Radias Phenylalanine Test
- Applicant
- BIO-RAD
- 510(k) number
- K960437
- Product code
- JNB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-16
- Date received
- 1996-01-31
- Regulation
- 862.1555
- Classification name
- Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- TREVOR WALL
- Address
- 4000 Alfred Nobel Dr. Hercules CA US 94547 94547
FDA Registration Numbers#
- 8043909
- 3050015
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JNB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021541 | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT | Perkinelmer Life Sciences | 2002-10-28 |
| K003584 | NEOLYNX SCREENING APPLICATION MANAGER | Micromass, Inc. | 2001-03-19 |
| K000754 | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 2000-06-19 |
| K984463 | QUANTASE PHE/GAL SCREENING ASSAY | Quantase , Ltd. | 1999-02-16 |
| K982307 | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | Wallac, Inc. | 1999-02-02 |
| K974047 | ACCUWELL PHENYLALANINE ASSAY | Neometrics, Inc. | 1997-12-05 |
| K963040 | MANUAL PHENYLALANINE TEST | Bio-Rad | 1996-10-01 |
| K961515 | QUANTASE PHENYLALANINE ASSAY | Shield Diagnostics, Ltd. | 1996-06-12 |
| K943547 | PHENYLALANINE TEST KIT | Isolab, Inc. | 1996-01-26 |
| K926106 | IMMUCHEM PHE-MW EA | Icn Biomedicals, Inc. | 1995-02-08 |
| K922547 | QUANTASE PHENYLALANINE ASSAY | Porton Cambridge , Ltd. | 1994-10-13 |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Alpkem Corp. | 1989-10-27 |
| K813449 | PHE/TYR KINETIC UV TEST SET | P-L Biochemicals, Inc. | 1981-12-31 |
| K813171 | PHENYLALANINE UV KINETIC TEST KIT | Biochemicals, Inc. | 1981-12-03 |