The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Calcium (ocpc) Liquid Reagent.
| Device ID | K041009 |
| 510k Number | K041009 |
| Device Name: | RAICHEM CALCIUM (OCPC) LIQUID REAGENT |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | James J Miller |
| Correspondent | James J Miller HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-06-25 |