The following data is part of a premarket notification filed by Ultra Quest Diagnostics, Inc. with the FDA for Ultra Lyte Sodium Reagent Kit.
Device ID | K843453 |
510k Number | K843453 |
Device Name: | ULTRA LYTE SODIUM REAGENT KIT |
Classification | Electrode, Ion Specific, Sodium |
Applicant | ULTRA QUEST DIAGNOSTICS, INC. 1404 NORTH MAIN STREET Indianapolis , IN 46224 - |
Contact | Brady |
Correspondent | Brady ULTRA QUEST DIAGNOSTICS, INC. 1404 NORTH MAIN STREET Indianapolis , IN 46224 - |
Product Code | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-05 |
Decision Date | 1984-11-27 |