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AIA-PACK CTNI 2ND-GEN ASSAY

Page Type
Cleared 510(K)
510(k) Number
K012820
510(k) Type
Traditional
Applicant
TOSOH MEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/14/2001
Days to Decision
113 days
Submission Type
Statement

AIA-PACK CTNI 2ND-GEN ASSAY

Page Type
Cleared 510(K)
510(k) Number
K012820
510(k) Type
Traditional
Applicant
TOSOH MEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/14/2001
Days to Decision
113 days
Submission Type
Statement