The following data is part of a premarket notification filed by Scientific Manufacturing Industries with the FDA for Smi Multi-tube Vortexer.
Device ID | K801145 |
510k Number | K801145 |
Device Name: | SMI MULTI-TUBE VORTEXER |
Classification | Shaker/stirrer |
Applicant | SCIENTIFIC MANUFACTURING INDUSTRIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JRQ |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-13 |
Decision Date | 1980-06-09 |