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510(k) K870860

CHEMPRO 1000(TM) by Arden Medical Systems, Inc. — Product Code GKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hematocrit, Automated
Device Class
Class II
Regulation Number
864.5600
Review Panel
HE
Submission Type

Other clearances by Arden Medical Systems, Inc.

  • K883012 — A.QC CHEMISTRY CONTROL LEVEL 2 (September 9, 1988)
  • K873611 — A-QC CLINICAL CHEMISTRY CONTROL (October 20, 1987)

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  • K983551 — CRIT-SCAN II MONITOR (May 27, 1999)
  • K981427 — STAT PROFILE M ANALYZER (May 12, 1998)
  • K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (May 12, 1998)
  • K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (May 12, 1998)
  • K953519 — MICROSPIN 24 (November 3, 1995)
  • K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (March 11, 1992)
  • K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (January 8, 1992)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K880373 — IONOMETER E-HK AND ACCESSORIES (March 17, 1988)