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ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

Page Type
Cleared 510(K)
510(k) Number
K121533
510(k) Type
Traditional
Applicant
Tosoh Bioscience, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/15/2012
Days to Decision
22 days
Submission Type
Summary

ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

Page Type
Cleared 510(K)
510(k) Number
K121533
510(k) Type
Traditional
Applicant
Tosoh Bioscience, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/15/2012
Days to Decision
22 days
Submission Type
Summary