BIOCENTREX CARDIAC PANEL— 510(k) K033155

Substantially Equivalent

Biocentrex

FDA 510(k) clearance K033155 for BIOCENTREX CARDIAC PANEL, Substantially Equivalent on 2004-01-12. Applicant: Biocentrex. Device class: 2.

Clearance details

Applicant
Biocentrex
Product code
Code MYT
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Culver City, CA, US
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