PRO-STEP LH OVULATION PREDICTION TEST

Radioimmunoassay, Luteinizing Hormone

DISEASE DETECTION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Pro-step Lh Ovulation Prediction Test.

Pre-market Notification Details

Device IDK943252
510k NumberK943252
Device Name:PRO-STEP LH OVULATION PREDICTION TEST
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine,  CA  92718
ContactSiegfried Krutzik
CorrespondentSiegfried Krutzik
DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine,  CA  92718
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-06
Decision Date1994-10-25

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