The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Bio-tek Automated Microplate Washer Model El403.
Device ID | K884125 |
510k Number | K884125 |
Device Name: | BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
Contact | Dan Contois |
Correspondent | Dan Contois BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-30 |
Decision Date | 1988-12-02 |