Last synced on 17 March 2023 at 11:04 pm

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K063232
510(k) Type
Traditional
Applicant
BIOKIT S.A.
Country
Spain
FDA Decision
Substantially Equivalent
Decision Date
6/19/2007
Days to Decision
237 days
Submission Type
Summary

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K063232
510(k) Type
Traditional
Applicant
BIOKIT S.A.
Country
Spain
FDA Decision
Substantially Equivalent
Decision Date
6/19/2007
Days to Decision
237 days
Submission Type
Summary