The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Els 1000.
| Device ID | K933548 |
| 510k Number | K933548 |
| Device Name: | ELS 1000 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Contact | Michael N Sevigny |
| Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-20 |
| Decision Date | 1993-10-29 |