CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION

System, Multipurpose For In Vitro Coagulation Studies

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Calcium Chloride/diethylbarb Acetate Buff Solution.

Pre-market Notification Details

Device IDK924509
510k NumberK924509
Device Name:CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJoseph Kiceina
CorrespondentJoseph Kiceina
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-04
Decision Date1992-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768014222 K924509 000
00842768018916 K924509 000

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