The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Meloy Lab-antinuclear Antibody Test-hep-2 Cell Cul.
| Device ID | K844678 |
| 510k Number | K844678 |
| Device Name: | MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | MELOY LABORATORIES, INC. 6715 ELECTRONIC DR. Springfield, VA 22151 |
| Contact | Robert H Fennell |
| Correspondent | Robert H Fennell MELOY LABORATORIES, INC. 6715 ELECTRONIC DR. Springfield, VA 22151 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-30 |
| Decision Date | 1985-01-04 |