The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Titertek Microplate Washer 120.
Device ID | K844500 |
510k Number | K844500 |
Device Name: | TITERTEK MICROPLATE WASHER 120 |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
Contact | Joy F Poppe |
Correspondent | Joy F Poppe FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-20 |
Decision Date | 1985-01-22 |