510(k) K041408

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

K041408 is an FDA 510(k) premarket notification submitted by Polymedco, Inc. for the device "POLYMEDCO OC AUTO MICRO 80 FOB TEST". The FDA issued a decision of Substantially Equivalent on October 21, 2004. The device falls under product code OOX (Automated Occult Blood Analyzer), a Class II device regulated under 21 CFR 864.6550. Polymedco, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Polymedco, Inc.

K112408 — POLY-CHEM 90 ISE MODULE (November 4, 2011)
K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI (September 8, 2011)
K111143 — POLY-CHEM 90 TOTAL BILIRUBIN (September 1, 2011)
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

FDA data resources