The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Pr 3 Antibody Kit.
| Device ID | K973823 |
| 510k Number | K973823 |
| Device Name: | PR 3 ANTIBODY KIT |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
| Contact | Joseph Califano |
| Correspondent | Joseph Califano HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1997-11-13 |
| Summary: | summary |