The following data is part of a premarket notification filed by Scientific Manufacturing Industries with the FDA for Smi Digitron.
Device ID | K840186 |
510k Number | K840186 |
Device Name: | SMI DIGITRON |
Classification | Micro Pipette |
Applicant | SCIENTIFIC MANUFACTURING INDUSTRIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JRC |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-18 |
Decision Date | 1984-04-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMI DIGITRON 73512017 1347481 Dead/Cancelled |
AMERICAN HOSPITAL SUPPLY CORPORATION 1984-12-04 |