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510(k) K964960

Device
VITROS CHEMISTRY PRODUCTS UPRO SLIDES
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
510(k) number
K964960
Product code
JGP  
Decision
Substantially Equivalent (SESE)
Decision date
1997-02-18
Date received
1996-12-11
Regulation
862.1635
Classification name
Lowry (colorimetric), Total Protein
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHARLES C MORGANSON, JR.
Address
100 Indigo Creek Dr. Rochester NY US 14650 14650

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JGP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070757MICROPROTEIN REAGENT SETPointe Scientific, Inc.,2007-12-04
K863112PROTEINMETERJ. D. Assoc.1986-12-10
K821534HEMATOLOGY DATA MANAGEMENT SYSBiovation, Inc.1982-06-10
K792347MICRO LOWRY PROTEINTESTPanmed, Inc.1979-12-06

Legacy Summary#

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FDA Review#

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