MANUAL PHENYLALANINE TEST
FDA 510(k) clearance K963040 · decided 1996-10-01
Clearance details
- K-number
- K963040
- Device name
- MANUAL PHENYLALANINE TEST
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1996-08-05
- Decision date
- 1996-10-01
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JNB
- Device class
- 2
- Regulation number
- 862.1555
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (K021541) | Perkinelmer Life Sciences | 2002-10-28 |
| NEOLYNX SCREENING APPLICATION MANAGER (K003584) | Micromass, Inc. | 2001-03-19 |
| QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (K000754) | Quantase , Ltd. | 2000-06-19 |
| QUANTASE PHE/GAL SCREENING ASSAY (K984463) | Quantase , Ltd. | 1999-02-16 |
| WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (K982307) | Wallac, Inc. | 1999-02-02 |
| ACCUWELL PHENYLALANINE ASSAY (K974047) | Neometrics, Inc. | 1997-12-05 |
| RADIAS PHENYLALANINE TEST (K960437) | Bio-Rad | 1996-08-16 |
| QUANTASE PHENYLALANINE ASSAY (K961515) | Shield Diagnostics, Ltd. | 1996-06-12 |
| PHENYLALANINE TEST KIT (K943547) | Isolab, Inc. | 1996-01-26 |
| IMMUCHEM PHE-MW EA (K926106) | Icn Biomedicals, Inc. | 1995-02-08 |
| QUANTASE PHENYLALANINE ASSAY (K922547) | Porton Cambridge , Ltd. | 1994-10-13 |
| PHENYLALANINE (NINHYDRIN REACTION) (K891070) | Alpkem Corp. | 1989-10-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |