The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Prealbumin Spia.
| Device ID | K972812 |
| 510k Number | K972812 |
| Device Name: | RAICHEM PREALBUMIN SPIA |
| Classification | Prealbumin, Fitc, Antigen, Antiserum, Control |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
| Contact | Joseph M Califano |
| Correspondent | Joseph M Califano HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
| Product Code | DDS |
| CFR Regulation Number | 866.5060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1997-08-28 |
| Summary: | summary |