TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL

C-reactive Protein, Antigen, Antiserum, And Control

SIMPLICITY DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Simplicity Diagnostics, Inc. with the FDA for Tech Dimple C-reactive Protein Serum Control.

Pre-market Notification Details

Device IDK922722
510k NumberK922722
Device Name:TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant SIMPLICITY DIAGNOSTICS, INC. P.O. BOX 730 21 N. YORK ROAD Hatboro,  PA  19040
ContactJeffrey Fleishman
CorrespondentJeffrey Fleishman
SIMPLICITY DIAGNOSTICS, INC. P.O. BOX 730 21 N. YORK ROAD Hatboro,  PA  19040
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-05
Decision Date1992-10-05

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