Last synced on 23 September 2022 at 11:05 pm

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060818
510(k) Type
Traditional
Applicant
BIOKIT S.A.
Country
Spain
FDA Decision
Substantially Equivalent
Decision Date
1/23/2007
Days to Decision
302 days
Submission Type
Summary

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060818
510(k) Type
Traditional
Applicant
BIOKIT S.A.
Country
Spain
FDA Decision
Substantially Equivalent
Decision Date
1/23/2007
Days to Decision
302 days
Submission Type
Summary