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510(k) K880242

KONE CALCIUM TEST by The Rupp & Bowman Co. — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1988
Date Received
January 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by The Rupp & Bowman Co.

  • K880973 — MICROLYTE 7 (September 7, 1988)
  • K882081 — SPECIFIC CHEMISTRY ANALYZER (July 1, 1988)

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  • K120626 — EON CALCIUM REGENT (August 22, 2012)
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  • K072356 — S-TEST CA (June 24, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (September 24, 2007)