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510(k) K110818

POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS by Polymedco, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2011
Date Received
March 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Polymedco, Inc.

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  • 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)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)
  • 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)

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