K980736 is an FDA 510(k) clearance for the ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Acon Laboratories Co. (Bethlehem, US). The FDA issued a Cleared decision on April 16, 1998, 50 days after receiving the submission on February 25, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K980736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1998 |
| Decision Date | April 16, 1998 |
| Days to Decision | 50 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 |