The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Folate.
| Device ID | K023397 |
| 510k Number | K023397 |
| Device Name: | ABBOTT ARCHITECT FOLATE |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 -6187 |
| Contact | Margaret Prochniak |
| Correspondent | Margaret Prochniak ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 -6187 |
| Product Code | CGN |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-09 |
| Decision Date | 2002-12-16 |
| Summary: | summary |