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510(k) K941712

Device
COBAS-FP REAGENTS AND CALIBRATORS
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K941712
Product code
LGJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-13
Date received
1994-04-06
Regulation
862.3035
Classification name
Fluorescence Polarization Immunoassay, Amibacin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROL L KRIEGER
Address
1080 Us Hwy. 202 Branchburg NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LGJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991597COBAS INTEGRA AMIKACIN MABRoche Diagnostics Corp.1999-07-22
K862248AMIKACIN KIT (FPIA)Windsor Laboratories, Inc.1986-08-04

Legacy Summary#

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FDA Review#

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