The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Cesium Diluent 7.5m.
Device ID | K811886 |
510k Number | K811886 |
Device Name: | CESIUM DILUENT 7.5M |
Classification | Flame Photometry, Sodium |
Applicant | GILFORD DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JGT |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-01 |
Decision Date | 1981-07-23 |