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510(k) K980043

CARESIDE CREATININE by Exigent Diagnostics, Inc. — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1998
Date Received
January 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Exigent Diagnostics, Inc.

  • K982118 — CARESIDE ANALYZER (July 24, 1998)
  • K981899 — CARESIDE HDL-CHOLESTEROL (July 14, 1998)
  • K981183 — CARESIDE GLUCOSE (May 7, 1998)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K980057 — CARESIDE BUN (February 5, 1998)
  • K980041 — CARESIDE ALBUMIN (February 4, 1998)
  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 1998)
  • K980055 — CARESIDE GLOBULIN (January 28, 1998)

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  • K183555 — GEM Premier ChemSTAT (February 16, 2019)
  • K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (December 10, 2018)
  • K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VI (October 30, 2018)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbu (December 22, 2014)