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MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12

Page Type
Cleared 510(K)
510(k) Number
K042362
510(k) Type
Traditional
Applicant
DIAGNOSTIC CHEMICALS LTD.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
12/27/2004
Days to Decision
118 days
Submission Type
Statement

MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12

Page Type
Cleared 510(K)
510(k) Number
K042362
510(k) Type
Traditional
Applicant
DIAGNOSTIC CHEMICALS LTD.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
12/27/2004
Days to Decision
118 days
Submission Type
Statement