RDI DIRECT LDL CHOLESTEROL TEST— 510(k) K984107

Substantially Equivalent

Reference Diagnostics, Inc.

FDA 510(k) clearance K984107 for RDI DIRECT LDL CHOLESTEROL TEST, Substantially Equivalent on 1999-01-28. Applicant: Reference Diagnostics, Inc..

Clearance details

Applicant: Reference Diagnostics, Inc.
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 1998-11-17
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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