The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Titertek Microplate Incubator.
Device ID | K812340 |
510k Number | K812340 |
Device Name: | TITERTEK MICROPLATE INCUBATOR |
Classification | Bath, Incubators/water, All |
Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTQ |
CFR Regulation Number | 866.2540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-18 |
Decision Date | 1981-09-23 |