The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Midstream Pregnancy Test.
| Device ID | K983090 |
| 510k Number | K983090 |
| Device Name: | ACON MIDSTREAM PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ACON LABORATORIES, INC. 3140-B TILGHMAN ST. SUITE 215 Allentown, PA 18104 |
| Contact | Patricia E Bonness |
| Correspondent | Patricia E Bonness ACON LABORATORIES, INC. 3140-B TILGHMAN ST. SUITE 215 Allentown, PA 18104 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-03 |
| Decision Date | 1998-11-18 |
| Summary: | summary |