FDA Product Code
FDA Product Code NAL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1155
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K012943 | THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE | Quantech , Ltd. | 2002-01-18 | Traditional | PDF ↗ |
| K990258 | QUANTECH TOTAL B-HCG ASSAY | Quantech , Ltd. | 1999-12-21 | Traditional | PDF ↗ |
Product code NAL · Class II · Clinical Chemistry. Data: openFDA.