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AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

Page Type
Cleared 510(K)
510(k) Number
K083222
510(k) Type
Traditional
Applicant
Axis-Shield Diagnostics, Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/31/2009
Days to Decision
270 days
Submission Type
Summary

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

Page Type
Cleared 510(K)
510(k) Number
K083222
510(k) Type
Traditional
Applicant
Axis-Shield Diagnostics, Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/31/2009
Days to Decision
270 days
Submission Type
Summary