The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric.
| Device ID | K121823 |
| 510k Number | K121823 |
| Device Name: | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC |
| Classification | Coulometric, Chloride |
| Applicant | WESCOR, INC. 370 West 1700 South Logan, UT 84321 |
| Contact | Dawn T Perdue |
| Correspondent | Dawn T Perdue WESCOR, INC. 370 West 1700 South Logan, UT 84321 |
| Product Code | JFS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-21 |
| Decision Date | 2013-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540304088 | K121823 | 000 |
| 03661540304101 | K121823 | 000 |
| 03661540304095 | K121823 | 000 |