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 |