Cleared Traditional

K060215 - ALBU TROL, LOW, MODEL 108.001.002 (FDA 510(k) Clearance)

Also includes:
ALBU TROL, HIGH 108.002.002
K060215 · Eurotrol B.V. · Chemistry device
Mar 2006
Decision
56d
Days
Class 1
Risk

K060215 is an FDA 510(k) clearance for the ALBU TROL, LOW, MODEL 108.001.002. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).

Submitted by Eurotrol B.V. (Lake Forest, US). The FDA issued a Cleared decision on March 24, 2006, 56 days after receiving the submission on January 27, 2006.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K060215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2006
Decision Date March 24, 2006
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX - Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.1660