FDA.reportPublic FDA data

510(k) K760430

Device
Bun-reative
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K760430
Product code
CDS
Decision
Substantially Equivalent (SESE)
Decision date
1976-11-01
Date received
1976-08-13
Regulation
862.1770
Classification name
Electrode, Ion Specific, Urea Nitrogen
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 CDS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc.2018-01-17
K040973BUN REAGENTGenchem, Inc.2004-12-27
K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTDiamond Diagnostics, Inc.2004-01-30
K925550HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806Hichem Diagnostics1993-04-20
K860543BLOOD UREA NITROGEN (BUN) TESTCARDIlex Corp.1986-04-21
K855091CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYSSen Tech Medical Corp.1986-03-14
K812308LANCER BUN RATE REAGENT KITSherwood Medical Co.1981-08-31
K811193BUN RATE REAGENTChem-Elec, Inc.1981-07-10
K800616BUN REAGENT KIT #88108Hi Chem, Inc.1980-04-10
K800590BUN KITNobel Scientific Industries, Inc.1980-04-04
K800071BUN REAGENT KITFisher Scientific Co., LLC1980-02-05
K791018FERMCOTEST R BUN RATE REAGENT TEST KITFermco Biochemics, Inc.1979-07-17
K771060DIAG. CONDUCTA RATE BUN REAG. SETJ.T. Baker Chemical Co.1977-07-21
K761061BLOOD-UREA-NITROGEN (BUN) ANALYZER 2Beckman Instruments, Inc.1977-01-25