FDA Product Code
FDA Product Code CHW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1145
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | Biosystems S.A. | 2020-09-09 | Traditional | PDF ↗ |
| K113521 | CALCIUM GEN. 2 | Roche Diagnostics | 2012-05-08 | Traditional | PDF ↗ |
| K781454 | LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA | Union Carbide Corp. | 1978-09-20 | Traditional | PDF ↗ |
Product code CHW · Class II · Clinical Chemistry. Data: openFDA.