The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon One Step Home Pregnancy Test Strip.
Device ID | K993483 |
510k Number | K993483 |
Device Name: | ACON ONE STEP HOME PREGNANCY TEST STRIP |
Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
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 | LCX |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-14 |
Decision Date | 2000-01-20 |
Summary: | summary |