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DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL

Page Type
Cleared 510(K)
510(k) Number
K071971
510(k) Type
Special
Applicant
Diazyme Laboratories
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/17/2007
Days to Decision
62 days
Submission Type
Statement

DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL

Page Type
Cleared 510(K)
510(k) Number
K071971
510(k) Type
Special
Applicant
Diazyme Laboratories
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/17/2007
Days to Decision
62 days
Submission Type
Statement