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510(k) K952555

Device
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K952555
Product code
MOJ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-31
Date received
1995-06-02
Regulation
862.3350
Classification name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (free)
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RITA SMITH
Address
Branchburg Township 1080 U.S. Hwy. 202 Somerville NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MOJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230161ONLINE TDM Phenytoin - Free Phenytoin applicationRoche Diagnostics2023-03-30
K950280TDX(R)/TDXFLX(R) FREE PHENYTOIN IIAbbott Laboratories1995-05-02

Legacy Summary#

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FDA Review#

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