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510(k) K113521

Device
CALCIUM GEN. 2
Applicant
Roche Diagnostics
510(k) number
K113521
Product code
CHW  
Decision
Substantially Equivalent (SESE)
Decision date
2012-05-08
Date received
2011-11-29
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
LISA K KLINEDINST
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CHW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192730CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UVBiosystems S.A.2020-09-09
K781454LINDE OXYGEN CONCENTRATOR MODEL LOC-HCAUnion Carbide Corp.1978-09-20

Legacy Summary#

summary

FDA Review#

Decision Summary