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AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

Page Type
Cleared 510(K)
510(k) Number
K980907
510(k) Type
Traditional
Applicant
AXIS BIOCHEMICALS, ASA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/1998
Days to Decision
220 days
Submission Type
Summary

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

Page Type
Cleared 510(K)
510(k) Number
K980907
510(k) Type
Traditional
Applicant
AXIS BIOCHEMICALS, ASA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/1998
Days to Decision
220 days
Submission Type
Summary