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AIA-PACK TROPONIN I ASSAY

Page Type
Cleared 510(K)
510(k) Number
K984359
510(k) Type
Traditional
Applicant
TOSOH MEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/1998
Days to Decision
16 days
Submission Type
Statement

AIA-PACK TROPONIN I ASSAY

Page Type
Cleared 510(K)
510(k) Number
K984359
510(k) Type
Traditional
Applicant
TOSOH MEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/1998
Days to Decision
16 days
Submission Type
Statement