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ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041866
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
9/29/2004
Days to Decision
82 days
Submission Type
Summary

ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041866
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
9/29/2004
Days to Decision
82 days
Submission Type
Summary