The following data is part of a premarket notification filed by Abbott Laboratories Inc with the FDA for Architect Ivalproic Acid Reagents And Architect Ivalproic Acid Calibrators, Models 1p35, 1p35.
| Device ID | K090358 |
| 510k Number | K090358 |
| Device Name: | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP6C-2; DEPT 049C Abbott Park, IL 60064 |
| Contact | Judi Wallach |
| Correspondent | Judi Wallach ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP6C-2; DEPT 049C Abbott Park, IL 60064 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-12 |
| Decision Date | 2009-08-06 |
| Summary: | summary |