CLP 0.1 M SODIUM CITRATE SOLUTION

System, Multipurpose For In Vitro Coagulation Studies

CREATIVE LABORATORY PRODUCTS, INC.

The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp 0.1 M Sodium Citrate Solution.

Pre-market Notification Details

Device IDK880713
510k NumberK880713
Device Name:CLP 0.1 M SODIUM CITRATE SOLUTION
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis,  IN  46268
ContactRoy Speck
CorrespondentRoy Speck
CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis,  IN  46268
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-22
Decision Date1988-03-18

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