The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Fluorescent Anti-native Dna Test.
| Device ID | K780899 |
| 510k Number | K780899 |
| Device Name: | FLUORESCENT ANTI-NATIVE DNA TEST |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-02 |
| Decision Date | 1978-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847865019347 | K780899 | 000 |
| 00847865019330 | K780899 | 000 |
| 00847865001571 | K780899 | 000 |
| 00847865001564 | K780899 | 000 |
| 00847865001557 | K780899 | 000 |
| 00847865001540 | K780899 | 000 |
| 00847865001533 | K780899 | 000 |
| 00847865001526 | K780899 | 000 |