The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Imx Folate.
| Device ID | K943691 |
| 510k Number | K943691 |
| Device Name: | IMX FOLATE |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | ABBOTT MFG., INC. 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Contact | Laura L Granitz |
| Correspondent | Laura L Granitz ABBOTT MFG., INC. 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-29 |
| Decision Date | 1995-03-23 |