Last synced on 25 January 2026 at 3:41 am

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K991733
510(k) Type
Traditional
Applicant
Schiapparelli Biosystems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/1999
Days to Decision
53 days
Submission Type
Summary

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K991733
510(k) Type
Traditional
Applicant
Schiapparelli Biosystems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/1999
Days to Decision
53 days
Submission Type
Summary