ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST — Acon Laboratories Co. (510(k) K980736)
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST — Acon Laboratories Co. (510(k) K980736) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST; Applicant: Acon Laboratories Co.; Clearance track: 510(k).
| Device name | ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST |
|---|---|
| Applicant | Acon Laboratories Co. |
| Clearance track | 510(k) |
| Submission number | K980736 |
| Decision | Substantially Equivalent |
| Decision date | 1998-04-16 |
| Date received | 1998-02-25 |
| Product code | JHI |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | PA, US |
| Source | openFDA device |
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$1999/mo
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