The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Hep-2 Cell Line Substrate.
| Device ID | K810863 |
| 510k Number | K810863 |
| Device Name: | KALLESTAD HEP-2 CELL LINE SUBSTRATE |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-31 |
| Decision Date | 1981-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847865019354 | K810863 | 000 |
| 00847865001588 | K810863 | 000 |
| 00847865001595 | K810863 | 000 |
| 00847865001601 | K810863 | 000 |
| 00847865001618 | K810863 | 000 |
| 00847865001625 | K810863 | 000 |
| 00847865001632 | K810863 | 000 |
| 00847865001649 | K810863 | 000 |
| 00847865001656 | K810863 | 000 |
| 00847865001670 | K810863 | 000 |
| 00847865001687 | K810863 | 000 |
| 00847865001731 | K810863 | 000 |
| 00847865001755 | K810863 | 000 |
| 00847865001762 | K810863 | 000 |
| 00847865001779 | K810863 | 000 |
| 00847865017244 | K810863 | 000 |
| 00847865017343 | K810863 | 000 |
| 00847865001205 | K810863 | 000 |