The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Autoclix.
| Device ID | K810075 |
| 510k Number | K810075 |
| Device Name: | AUTOCLIX |
| Classification | Lancet, Blood |
| Applicant | BIODYNAMICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-02-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AUTOCLIX 73377442 1282317 Dead/Cancelled |
Boehringer Mannheim GmbH 1982-07-30 |