The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Diluent, Zeroing Solution & Co-ox/ise.
Device ID | K823535 |
510k Number | K823535 |
Device Name: | DILUENT, ZEROING SOLUTION & CO-OX/ISE |
Classification | Gas Chromatograph, Carbon-monoxide |
Applicant | SHABAN MFG. CO. MD |
Product Code | JKT |
CFR Regulation Number | 862.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-30 |
Decision Date | 1983-01-28 |