WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST

Visual, Pregnancy Hcg, Prescription Use

W.H.P.M., INC.

The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for Wh Accu Test One-step Urine/serum Combo Pregnancy Test.

Pre-market Notification Details

Device IDK051841
510k NumberK051841
Device Name:WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant W.H.P.M., INC. 163 CABOT ST. Beverly,  MA  01915
ContactFran White
CorrespondentFran White
W.H.P.M., INC. 163 CABOT ST. Beverly,  MA  01915
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-07
Decision Date2005-08-22
Summary:summary

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