ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL— 510(k) K871265

Name: FDA 510(k) clearance K871265
Creator: U.S. Food and Drug Administration
Published: 1987-08-13

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K871265 for ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL, Substantially Equivalent on 1987-08-13. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1987-03-31
Decision date: 1987-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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