The following data is part of a premarket notification filed by Cappel Diagnostics, Inc. with the FDA for Anti-ndna Antibody Test Kit.
| Device ID | K864275 |
| 510k Number | K864275 |
| Device Name: | ANTI-NDNA ANTIBODY TEST KIT |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | CAPPEL DIAGNOSTICS, INC. P.O. BOX 4027 Davis, CA 95617 -4027 |
| Contact | Virginia Cappel |
| Correspondent | Virginia Cappel CAPPEL DIAGNOSTICS, INC. P.O. BOX 4027 Davis, CA 95617 -4027 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-29 |
| Decision Date | 1986-12-15 |