APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1— 510(k) K854875

Name: FDA 510(k) clearance K854875
Creator: U.S. Food and Drug Administration
Published: 1986-01-24

Substantially Equivalent

Photec Diagnostics, Inc.

FDA 510(k) clearance K854875 for APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1, Substantially Equivalent on 1986-01-24. Applicant: Photec Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Photec Diagnostics, Inc.
Product code: Code DER
Device class: Class 2
Regulation: 21 CFR 866.5580
Advisory panel: Immunology
Date received: 1985-12-04
Decision date: 1986-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Falls, NJ, US

Download summary PDF View on FDA.gov ↗

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