The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for Encore Chemistry Analyzer.
Device ID | K832716 |
510k Number | K832716 |
Device Name: | ENCORE CHEMISTRY ANALYZER |
Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
Applicant | BAKER INSTRUCTIONS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJG |
CFR Regulation Number | 862.2140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-12 |
Decision Date | 1983-10-04 |