The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Modification To Raichem Calcium Reagent.
| Device ID | K022049 |
| 510k Number | K022049 |
| Device Name: | MODIFICATION TO RAICHEM CALCIUM REAGENT |
| Classification | Azo Dye, Calcium |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Jose A Montanez |
| Correspondent | Jose A Montanez HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2002-07-19 |