Last synced on 4 February 2023 at 10:33 pm

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K062467
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/22/2006
Days to Decision
90 days
Submission Type
Summary

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K062467
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/22/2006
Days to Decision
90 days
Submission Type
Summary