ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS— 510(k) K991733

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K991733 for ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS, Substantially Equivalent on 1999-07-13. Applicant: Schiapparelli Biosystems, Inc..

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 1999-05-21
Decision date: 1999-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.