The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Automated Eia Microplate Reader Models El312/312i.
| Device ID | K901027 |
| 510k Number | K901027 |
| Device Name: | AUTOMATED EIA MICROPLATE READER MODELS EL312/312I |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Michael N Sevigny |
| Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-04-09 |