The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Titertek Microittration Equip. Handiwash 110 12cha.
Device ID | K850908 |
510k Number | K850908 |
Device Name: | TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA |
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 | 1985-03-05 |
Decision Date | 1985-03-25 |