Last synced on 25 January 2026 at 3:41 am

DIAZYME CYSTATIN C POC TEST KIT

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111664
510(k) Type
Traditional
Applicant
Diazyme Laboratories
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/2012
Days to Decision
290 days
Submission Type
Summary

DIAZYME CYSTATIN C POC TEST KIT

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111664
510(k) Type
Traditional
Applicant
Diazyme Laboratories
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/2012
Days to Decision
290 days
Submission Type
Summary