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 Number | 862.1555
|
Classification Product Code |
|
Subsequent Product Codes |
|
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
|
|
|