Cleared Traditional

MAS AND MINI-TROL PTH CONTROL

K092749 · Microgenics Corporation · Immunology
Dec 2009
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K092749 is an FDA 510(k) clearance for the MAS AND MINI-TROL PTH CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on December 3, 2009, 86 days after receiving the submission on September 8, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K092749 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2009
Decision Date December 03, 2009
Days to Decision 86 days
Submission Type Traditional
Review Panel Immunology (IM)
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

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