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510(k) K921206

HCG CONTROL by Polymedco, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1992
Date Received
March 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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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)
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  • K053553 — NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (March 9, 2006)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)
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  • K033706 — POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS (February 4, 2004)

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