LOK · Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
· Class 3
Overview
| Product Code | LOK |
|---|---|
| Device Name | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P120008 | ABBOTT ARCHITECT AFP ASSAY | Abbott Laboratories | Nov 28, 2012 | APPR |
| P010007 | IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP | Siemens Healthcare Diagnostics, Inc. | Nov 9, 2001 | APPR |
| P980041 | ACCESS AFP IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | Feb 8, 1999 | APPR |
| P970037 | AUTODELFIA HAFP TEST KIT | Revvity, Inc. | Mar 31, 1998 | APPR |
| P930036 | ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Sep 29, 1995 | APPR |
| P790032 | GAMMA DAB (125I) AFP RIA KIT | Incstar Corp. | Apr 30, 1986 | APWD |
| P780005 | ABBOTT AFP | Abbott Laboratories | Jun 25, 1984 | APWD |
| P780006 | AMERSHAM AFP | Ortho Clinical Diagnostics | Jun 7, 1984 | APWD |
| P800025 | QUANTITOPE 125I AFP KIT AND CONTROL SERUM | Bio-Rad Laboratories, Inc. | Jan 13, 1984 | APWD |
| P760001 | AFP RIA KIT | Alere, Inc. | Jan 13, 1984 | APWD |
| P820060 | ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER | Abbott Laboratories | Jun 21, 1983 | APWD |
Top Applicants
- Abbott Laboratories — 3 clearances
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
- Alere, Inc. — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Bio-Rad Laboratories, Inc. — 1 clearance
