The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Hcg One Step Pregnancy Test Device (urine).
| Device ID | K993317 |
| 510k Number | K993317 |
| Device Name: | ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ACON LABORATORIES, INC. 11175 FLINTKOTE AVE., #F San Diego, CA 92121 |
| Contact | Nora C.r. York |
| Correspondent | Nora C.r. York ACON LABORATORIES, INC. 11175 FLINTKOTE AVE., #F San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-12-01 |
| Summary: | summary |