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510(k) K021541

Device
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
Applicant
Perkinelmer Life Sciences
510(k) number
K021541
Product code
JNB
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-28
Date received
2002-05-10
Regulation
862.1555
Classification name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HANK JUSKE
Address
3985 Eastern Rd. Norton OH US 44203 44203

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JNB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003584NEOLYNX SCREENING APPLICATION MANAGERMicromass, Inc.2001-03-19
K000754QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KITQuantase , Ltd.2000-06-19
K984463QUANTASE PHE/GAL SCREENING ASSAYQuantase , Ltd.1999-02-16
K982307WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000Wallac, Inc.1999-02-02
K974047ACCUWELL PHENYLALANINE ASSAYNeometrics, Inc.1997-12-05
K963040MANUAL PHENYLALANINE TESTBio-Rad1996-10-01
K960437RADIAS PHENYLALANINE TESTBio-Rad1996-08-16
K961515QUANTASE PHENYLALANINE ASSAYShield Diagnostics, Ltd.1996-06-12
K943547PHENYLALANINE TEST KITIsolab, Inc.1996-01-26
K926106IMMUCHEM PHE-MW EAIcn Biomedicals, Inc.1995-02-08
K922547QUANTASE PHENYLALANINE ASSAYPorton Cambridge , Ltd.1994-10-13
K891070PHENYLALANINE (NINHYDRIN REACTION)Alpkem Corp.1989-10-27
K813449PHE/TYR KINETIC UV TEST SETP-L Biochemicals, Inc.1981-12-31
K813171PHENYLALANINE UV KINETIC TEST KITBiochemicals, Inc.1981-12-03