The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Selectalyte Electrolyte Analyzer (na+, K+, Cl-).
| Device ID | K171476 |
| 510k Number | K171476 |
| Device Name: | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | Awareness Technology, Inc. 1935 S.W Martin Hwy. Palm City, FL 34990 |
| Contact | Steve Andrus |
| Correspondent | Steve Andrus Awareness Technology, Inc. 1935 S.W Martin Hwy. Palm City, FL 34990 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-19 |
| Decision Date | 2018-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850229007348 | K171476 | 000 |
| 00850229007331 | K171476 | 000 |
| 00850229007324 | K171476 | 000 |
| 00850229007287 | K171476 | 000 |