PRO-STEP PT HCG

Visual, Pregnancy Hcg, Prescription Use

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 Pt Hcg.

Pre-market Notification Details

Device IDK925303
510k NumberK925303
Device Name:PRO-STEP PT HCG
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine,  CA  92718
ContactSiegfried Krutzik
CorrespondentSiegfried Krutzik
DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine,  CA  92718
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-21
Decision Date1993-06-15

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