Cleared Traditional

K032826 - MAS PAR TDM
(FDA 510(k) Clearance)

K032826 · Medical Analysis Systems, Inc. · Toxicology
Oct 2003
Decision
29d
Days
Class 1
Risk

K032826 is an FDA 510(k) clearance for the MAS PAR TDM. This device is classified as a Drug Mixture Control Materials (Class I — General Controls, product code DIF).

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on October 9, 2003, 29 days after receiving the submission on September 10, 2003.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K032826 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2003
Decision Date October 09, 2003
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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