The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Ca.
| Device ID | K981232 |
| 510k Number | K981232 |
| Device Name: | CA |
| Classification | Azo Dye, Calcium |
| Applicant | ABBOTT MFG., INC. 1920 HURD DR. Irving, TX 75038 |
| Contact | Mark Littlefield |
| Correspondent | Mark Littlefield ABBOTT MFG., INC. 1920 HURD DR. Irving, TX 75038 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-03 |
| Decision Date | 1998-05-18 |
| Summary: | summary |