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 |