510(k) K041408

POLYMEDCO OC AUTO MICRO 80 FOB TEST by Polymedco, Inc. — Product Code OOX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 21, 2004
Date Received: May 27, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Automated Occult Blood Analyzer
Device Class: Class II
Regulation Number: 864.6550
Review Panel: HE
Submission Type

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

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K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-C (September 28, 2010)
K090703 — POLY-CHEM 90 GLUCOSE (October 20, 2009)
K061944 — POLY-CHEM CREATININE (November 3, 2006)
K053553 — NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (March 9, 2006)
K041297 — POLYMEDCO OC LIGHT FOBT TEST (August 12, 2004)
K033706 — POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS (February 4, 2004)
K023654 — GLYCA-DIRECT FRUCTOSAMINE (May 2, 2003)

510(k) K041408

Clearance Details

Device Classification

Other clearances by Polymedco, Inc.

Other clearances for product code OOX