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510(k) K974534

Device
MICRO-PLATE COTININE EIA
Applicant
ORASURE TECHNOLOGIES, INC.
510(k) number
K974534
Product code
MKU  
Decision
Substantially Equivalent (SESE)
Decision date
1998-05-18
Date received
1997-12-02
Regulation
862.3220
Classification name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
R S NIEDBALA
Address
1745 Eaton Ave. Bethlehem PA US 18018 18018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MKU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192517Psychemedics Microplate EIA for Cotinine in HairPsychemedics Corporation2020-04-22
K192299LZI Cotinine II Enzyme ImmunoassayLin-Zhi International, Inc.2019-11-21
K062565STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINEPrinceton BioMeditech Corp.2007-02-20
K021944COZART EIA COTININE URINE KITCozart Bioscience , Ltd.2003-05-14
K974234MICRO-PLATE COTININE EIAOraSure Technologies, Inc.1998-05-14
K972481AUTO-LYTE COTININE EIAOraSure Technologies, Inc.1997-10-21

Legacy Summary#

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FDA Review#

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