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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine
510(k) Number K021541
Device Name NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
Applicant
PERKINELMER LIFE SCIENCES
3985 EASTERN RD.
NORTON,  OH  44203
Applicant Contact HANK JUSKE
Correspondent
PERKINELMER LIFE SCIENCES
3985 EASTERN RD.
NORTON,  OH  44203
Correspondent Contact HANK JUSKE
Regulation Number862.1555
Classification Product Code
JNB  
Subsequent Product Codes
CDR   JJE  
Date Received05/10/2002
Decision Date 10/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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