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510(k) K840213

Device
BLOOD UREA NITROGEN REAGENT SYS
Applicant
SCLAVO, INC.
510(k) number
K840213
Product code
JGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-19
Date received
1984-01-19
Regulation
862.1770
Classification name
O-phthalaldehyde, 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 JGZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904049ROCHE COBAS READY RENAL PROFILE REAGENT STRIPRoche Diagnostic Systems, Inc.1990-10-12
K896236COBAS READY BUN REAGENTRoche Diagnostic Systems, Inc.1990-02-27
K883327CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TESTHeraeus Kulzer, Inc.1989-01-23
K863901IQ UREA NITROGENBd Becton Dickinson Vacutainer Systems Preanalytic1986-11-24
K842772PHARMACIA B2-MICRO RIAPharmacia, Inc.1984-11-01
K820418K.D. COLORIMETRIC BLOOD UREA N2 TESTKing Diagnostics, Inc.1982-03-11
K810087UREA NITROGEN, KINETICBio-Analytics Laboratories, Inc.1981-02-26
K801269SERALYZER BLOOD UREA NITROGEN(BUN)Miles Laboratories, Inc.1980-07-08
K792362BLOOD UREA NITROGEN REAGENTConnecticut Diagnostics, Ltd.1979-12-06
K770504REAGENT SYSTEMAmerican Monitor Corp.1977-06-27

Legacy Summary#

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FDA Review#

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