The following data is part of a premarket notification filed by Technalysis, Inc. with the FDA for Techlyte Electrolyte Analyzer.
| Device ID | K905600 |
| 510k Number | K905600 |
| Device Name: | TECHLYTE ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | TECHNALYSIS, INC. 1805 RUTHERFORD LN. Austin, TX 78754 |
| Contact | Stephen C Biby |
| Correspondent | Stephen C Biby TECHNALYSIS, INC. 1805 RUTHERFORD LN. Austin, TX 78754 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-01-15 |