Device Classification Name |
ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine
|
510(k) Number |
K961515 |
Device Name |
QUANTASE PHENYLALANINE ASSAY |
Applicant |
SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
DUNDEE,
GB
DD2 1SW
|
|
Applicant Contact |
EILEEN MCCAFFERTY |
Correspondent |
SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
DUNDEE,
GB
DD2 1SW
|
|
Correspondent Contact |
EILEEN MCCAFFERTY |
Regulation Number | 862.1555
|
Classification Product Code |
|
Date Received | 04/10/1996 |
Decision Date | 06/12/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|