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510(k) K030649

Device
DRI COTININE EIA ASSAY
Applicant
MICROGENICS CORP.
510(k) number
K030649
Product code
MRS  
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-22
Date received
2003-02-28
Regulation
862.3220
Classification name
Test System, Nicotine, Cotinine, Metabolites
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAKSHMI ANNE
Address
46360 Fremont Blvd. Fremont Blvd. CA US 94538 94538

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021688NICALERTNymox Pharmaceutical Corporation2002-10-18
K963733NICCHECK IDynagen, Inc.1996-12-13

Legacy Summary#

summary

FDA Review#

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