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510(k) K781454

Device
LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA
Applicant
UNION CARBIDE CORP.
510(k) number
K781454
Product code
CHW  
Decision
Substantially Equivalent (SESE)
Decision date
1978-09-20
Date received
1978-08-22
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
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K192730CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UVBiosystems S.A.2020-09-09
K113521CALCIUM GEN. 2Roche Diagnostics2012-05-08

Legacy Summary#

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FDA Review#

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