OVULON MONITOR

Test, Luteinizing Hormone (lh), Over The Counter

CONCEPTION TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Conception Technology, Inc. with the FDA for Ovulon Monitor.

Pre-market Notification Details

Device IDK973860
510k NumberK973860
Device Name:OVULON MONITOR
ClassificationTest, Luteinizing Hormone (lh), Over The Counter
Applicant CONCEPTION TECHNOLOGY, INC. 214 S. COLLEGE AVE. Ft. Collins,  CO  80524
ContactTerry R Knapp, Md
CorrespondentTerry R Knapp, Md
CONCEPTION TECHNOLOGY, INC. 214 S. COLLEGE AVE. Ft. Collins,  CO  80524
Product CodeNGE  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-09
Decision Date1998-01-07

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