The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Bio-tek Automated Microplate Washer El402.
Device ID | K850249 |
510k Number | K850249 |
Device Name: | BIO-TEK AUTOMATED MICROPLATE WASHER EL402 |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | BIO-TEK INSTRUMENTS, INC. ONE MILL ST. Burlington, VT 05401 |
Contact | David Klyszeiko |
Correspondent | David Klyszeiko BIO-TEK INSTRUMENTS, INC. ONE MILL ST. Burlington, VT 05401 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-22 |
Decision Date | 1985-03-13 |