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510(k) K830032

Device
TOTAL IRON BINDING CAPACITY TEST
Applicant
SCLAVO, INC.
510(k) number
K830032
Product code
JQF  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-28
Date received
1983-01-07
Regulation
862.1415
Classification name
Bathophenanthroline, Iron Binding Capacity
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
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 JQF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051111SENTINEL UIBC LIQUIDSentinel Ch. Srl2005-11-17
K984122WAKO L-TYPE UIBC, WAKO UIBC CALIBRATORWako Chemicals USA, Inc.1999-01-20
K875176WAKO(TM) UIBCWako Chemicals USA, Inc.1988-02-02
K863066TRANSFERMETERJ. D. Assoc.1986-12-04
K811942J & S IRON SATURATING REAGENTThyroid Diagnostics, Inc.1981-09-08
K810086IRON & TICBBio-Analytics Laboratories, Inc.1981-01-28
K792409ELVI TOTAL IRON BINDING CAPACITYVolu Sol Medical Industries1979-12-06

Legacy Summary#

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FDA Review#

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