The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Quik-check Ii Midstream Home Pregnancy Test.
| Device ID | K032510 |
| 510k Number | K032510 |
| Device Name: | ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-14 |
| Decision Date | 2003-09-22 |
| Summary: | summary |