CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

Titrimetric With Edta And Indicator, Calcium

BioSystems S.A.

The following data is part of a premarket notification filed by Biosystems S.a. with the FDA for Calcium-cresolphthalein, Glucose, Urea/bun-uv.

Pre-market Notification Details

Device IDK192730
510k NumberK192730
Device Name:CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
ClassificationTitrimetric With Edta And Indicator, Calcium
Applicant BioSystems S.A. Costa Brava, 30 Barcelona,  ES
ContactNoelia Gil
CorrespondentNoelia Gil
BioSystems S.A. Costa Brava, 30 Barcelona,  ES
Product CodeCHW  
Subsequent Product CodeCDQ
Subsequent Product CodeCGA
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2020-09-09

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