The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Shaban 9865 Il#78637 Junction Bloc.
Device ID | K833804 |
510k Number | K833804 |
Device Name: | SHABAN 9865 IL#78637 JUNCTION BLOC |
Classification | Analyzer, Chemistry, Micro, For Clinical Use |
Applicant | SHABAN MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJF |
CFR Regulation Number | 862.2170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-01 |
Decision Date | 1984-01-13 |