K901045 is an FDA 510(k) clearance for the HCG SOLID PHASE COMPONENT SYSTEM. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 29, 1990, 23 days after receiving the submission on March 6, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K901045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1990 |
| Decision Date | March 29, 1990 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |