510(k) K113433

SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT by Focus Diagnostics, Inc. — Product Code OMN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 4, 2012
Date Received: November 21, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: C. Difficile Nucleic Acid Amplification Test Assay
Device Class: Class I
Regulation Number: 866.2660
Review Panel: MI
Submission Type

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

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K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)
K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (December 5, 2014)
K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)
DEN130049 — SIMPLEXA HSV 1&2 DIRECT (March 21, 2014)
K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (July 13, 2012)
DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)
K102170 — SIMPLEXA FLU A/B & RSV (November 24, 2010)

510(k) K113433

Clearance Details

Device Classification

Other clearances by Focus Diagnostics, Inc.

Other clearances for product code OMN