The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Dynawasher Ii.
Device ID | K800989 |
510k Number | K800989 |
Device Name: | DYNAWASHER II |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | DYNATECH LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-24 |
Decision Date | 1980-06-02 |