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 |