Device Classification Name |
Enzymatic Methods, Galactose
|
510(k) Number |
K990644 |
Device Name |
QUANTASE TOTAL GALACTOSE SCREENING ASSAY |
Applicant |
QUANTASE LTD. |
3 RIVERVIEW BUSINESS PARK |
FRIARTON ROAD |
PERTH, SCOTLAND,
GB
PH2 8DF
|
|
Applicant Contact |
R. STEWART CAMPBELL |
Correspondent |
QUANTASE LTD. |
3 RIVERVIEW BUSINESS PARK |
FRIARTON ROAD |
PERTH, SCOTLAND,
GB
PH2 8DF
|
|
Correspondent Contact |
R. STEWART CAMPBELL |
Regulation Number | 862.1310
|
Classification Product Code |
|
Date Received | 02/26/1999 |
Decision Date | 06/21/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|