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 |