The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Automated Eia Reader Model El311.
Device ID | K884124 |
510k Number | K884124 |
Device Name: | AUTOMATED EIA READER MODEL EL311 |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
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 | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-30 |
Decision Date | 1989-01-03 |