The following data is part of a premarket notification filed by Ultra Quest Diagnostics, Inc. with the FDA for Ultra Lyte Analyzer I 100.
| Device ID | K842315 |
| 510k Number | K842315 |
| Device Name: | ULTRA LYTE ANALYZER I 100 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | ULTRA QUEST DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-12 |
| Decision Date | 1984-08-02 |