Last synced on 14 November 2025 at 11:06 pm

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR

Page Type
Cleared 510(K)
510(k) Number
K061296
510(k) Type
Special
Applicant
DIAZYME LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2006
Days to Decision
35 days
Submission Type
Statement

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR

Page Type
Cleared 510(K)
510(k) Number
K061296
510(k) Type
Special
Applicant
DIAZYME LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2006
Days to Decision
35 days
Submission Type
Statement