The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Automated Elisa Reader Lbi 300.
Device ID | K830227 |
510k Number | K830227 |
Device Name: | AUTOMATED ELISA READER LBI 300 |
Classification | Bath, Incubators/water, All |
Applicant | BIONETIC LABORATORY PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTQ |
CFR Regulation Number | 866.2540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-24 |
Decision Date | 1983-03-10 |