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510(k) K192730

Device
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
Applicant
BioSystems S.A.
510(k) number
K192730
Product code
CHW  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-09
Date received
2019-09-27
Regulation
862.1145
Classification name
Titrimetric With Edta And Indicator, Calcium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Noelia Gil
Address
Costa Brava, 30 Barcelona ES

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CHW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K113521CALCIUM GEN. 2Roche Diagnostics2012-05-08
K781454LINDE OXYGEN CONCENTRATOR MODEL LOC-HCAUnion Carbide Corp.1978-09-20

Legacy Summary#

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FDA Review#

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