The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Folate Reagents, Architect Folate Calibrators, And Architect Folate Controls, Models 1p74, 1p74, 1p74.
| Device ID | K092740 |
| 510k Number | K092740 |
| Device Name: | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT. 9V6 AP6C-2 Abbott Park, IL 60064 |
| Contact | Darla Abano |
| Correspondent | Darla Abano ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT. 9V6 AP6C-2 Abbott Park, IL 60064 |
| Product Code | CGN |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-08 |
| Decision Date | 2010-03-05 |
| Summary: | summary |