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510(k) K950383

Device
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K950383
Product code
JHN  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-15
Date received
1995-01-31
Regulation
862.1475
Classification name
Turbidimetric Method, Lipoproteins
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
John Lamont
Address
55 Diamond Rd. Crumlin, Co. Antrim IE BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JHN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITRandox Laboratories, Ltd.1995-09-15
K952615WAKO AUTOKIT APO A1Wako Chemicals USA, Inc.1995-09-08
K952425OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1995-07-05
K952466OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1995-06-05
K932603APOLIPOPROTIEN B (APO B)Sigma Diagnostics, Inc.1994-06-02
K932606APOLIPOPROTIEN A-1 (APO A-1)Sigma Diagnostics, Inc.1994-06-02

Legacy Summary#

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FDA Review#

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