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510(k) K781885

Device
SERUM, BLOOD UREA NITIOGEN
Applicant
FISHER SCIENTIFIC CO., LLC.
510(k) number
K781885
Product code
CDW  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-20
Date received
1978-11-07
Regulation
862.1770
Classification name
Diacetyl-monoxime, 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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CDW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874532BLOOD UREA NITROGENCatachem, Inc.1988-01-05
K871320FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814American Research Products Co.1987-04-22
K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346American Research Products Co.1986-10-01
K861775TWIN BUN/GLUCOSEBoehringer Mannheim Corp.1986-06-27
K860419UREA NITROGEN REAGENT SETSterling Diagnostics, Inc.1986-02-11
K850937UREADilab, Inc.1985-06-10
K844156UREA NITROGEN REAGENT SETLivonia Diagnostics, Inc.1984-11-13
K841068UREA NITROGEN REAGENT SETMedical Specialties, Inc.1984-05-01
K822323ULTRACHEM BUN-UV, 65080 & 65081Harleco Diagnostics1982-09-02
K821212UREA NITROGEN REAGENT SETOmega Medical Electronics1982-07-22
K813415UREA NITROGEN REAGENT SETAnco Medical Reagents & Assoc.1981-12-31
K802160BUN COLOR REAGENT & BUN ACID USEDPanmed, Inc.1980-10-10
K800673SMAC REPLACEMENT REAGENTS/OF BUN-SERUMDiagnostic Solutions, Inc.1980-05-28
K781305UREA NITROGENAnalytical & Research Chemicals, Inc.1978-08-31
K780262DIRECT UREA NITROGEN TESTHycel, Inc.1978-04-05

Legacy Summary#

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FDA Review#

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