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510(k) K850932

CREATININE by Dilab, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
March 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Dilab, Inc.

  • K862530 — RAPID AS LATEX (April 21, 1987)
  • K850931 — ALBUMIN (June 26, 1985)
  • K850938 — CHOLESTEROL (June 25, 1985)
  • K850934 — PHOSPHORUS (June 25, 1985)
  • K850936 — TOTAL PROTEINS (June 25, 1985)
  • K850933 — URIC ACID (June 25, 1985)
  • K850935 — CHLORIDE (June 10, 1985)
  • K850937 — UREA (June 10, 1985)
  • K850930 — GLUCOSE (June 10, 1985)
  • K850929 — CALCIUM (June 10, 1985)

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  • K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 27, 2014)
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  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PE (April 30, 2012)