The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Automated Eia Microplate Reader El310.
Device ID | K842085 |
510k Number | K842085 |
Device Name: | AUTOMATED EIA MICROPLATE READER EL310 |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | BIO-TEK INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-24 |
Decision Date | 1984-06-11 |