K041946 is an FDA 510(k) clearance for the ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 16, 2004, 28 days after receiving the submission on July 19, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K041946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2004 |
| Decision Date | August 16, 2004 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |