The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Combo Pregnancy.
| Device ID | K993065 |
| 510k Number | K993065 |
| Device Name: | ACON COMBO PREGNANCY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ACON LABORATORIES, INC. 11175 FLINTKOTE AVE., #F San Diego, CA 92121 |
| Contact | Jixun Lin |
| Correspondent | Jixun Lin 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 | 1999-09-13 |
| Decision Date | 1999-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590776886 | K993065 | 000 |