The following data is part of a premarket notification filed by Conception Technology, Inc. with the FDA for Ovulon Monitor.
Device ID | K973860 |
510k Number | K973860 |
Device Name: | OVULON MONITOR |
Classification | Test, Luteinizing Hormone (lh), Over The Counter |
Applicant | CONCEPTION TECHNOLOGY, INC. 214 S. COLLEGE AVE. Ft. Collins, CO 80524 |
Contact | Terry R Knapp, Md |
Correspondent | Terry R Knapp, Md CONCEPTION TECHNOLOGY, INC. 214 S. COLLEGE AVE. Ft. Collins, CO 80524 |
Product Code | NGE |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-09 |
Decision Date | 1998-01-07 |