NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT


Device Classification Name

ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine

510(k) Number K021541
Device Name NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
Original Applicant
PERKINELMER LIFE SCIENCES
3985 eastern rd.
norton, 
OH 
44203

Original Contact hank juske
Regulation Number 862.1555
Classification Product Code
JNB  
Subsequent Product Codes
CDR   JJE  
Date Received 05/10/2002
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