The following data is part of a premarket notification filed by Cappel Diagnostics, Inc. with the FDA for Antinuclear Antibody Test.
| Device ID | K872839 |
| 510k Number | K872839 |
| Device Name: | ANTINUCLEAR ANTIBODY TEST |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | CAPPEL DIAGNOSTICS, INC. P.O. BOX 4027 Davis, CA 95617 -4027 |
| Contact | Virginia L Cappel |
| Correspondent | Virginia L Cappel CAPPEL DIAGNOSTICS, INC. P.O. BOX 4027 Davis, CA 95617 -4027 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-20 |
| Decision Date | 1987-10-20 |