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510(k) K141925

TOTAL PROTEIN URINE/CSF GEN.3 by Roche Diagnostics Operations (Rdo) — Product Code JIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2014
Date Received
July 16, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

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Other clearances for product code JIQ

  • K013643 — AUSAM TOTAL ALBUMIN ASSAY (August 14, 2003)
  • K991800 — HEMOCHEK URINE COLLECTION KIT (September 24, 1999)
  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • K965035 — IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT (April 17, 1997)
  • K944664 — WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (February 7, 1995)
  • K936202 — URINARY ALBUMIN TEST PACK (May 9, 1994)
  • K935662 — SYNERMED IR 500 CHEMISTRY ANALYZER (April 26, 1994)
  • K903123 — RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT (September 14, 1990)
  • K902216 — WAKO(TM) MICRO-ALBUMIN (June 18, 1990)
  • K895883 — BECKMAN MA MICROALBUMIN REAGENT KIT (December 27, 1989)