FDA Product Code
FDA Product Code CDA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1390
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K952817 | BIO-RAD URINARY 5-HIAA BY HPLC | Bio-Rad | 1995-08-01 | Traditional | PDF ↗ |
| K903609 | SEROTONIN ENZYME IMMUNOASSAY | Immunotech Corp. | 1990-10-22 | Traditional | PDF ↗ |
| K854946 | TDXR 5-HIAA (URINE) | Abbott Laboratories | 1986-01-17 | Traditional | PDF ↗ |
Product code CDA · Class I · Clinical Chemistry. Data: openFDA.