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510(k) K141925

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

K141925 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "TOTAL PROTEIN URINE/CSF GEN.3". The FDA issued a decision of Substantially Equivalent on December 9, 2014. The device falls under product code JIQ (Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.

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

Other clearances by Roche Diagnostics Operations (Rdo)

  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K183517 — Ammonia II (February 8, 2019)
  • K182095 — Tina-quant Transferrin ver.2 (urine application) (November 5, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 2017)
  • K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (December 19, 2016)
  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K161817 — Tina-quant Cystatin C Gen.2 (July 27, 2016)
  • K160570 — Creatine Kinase (May 25, 2016)
  • K152245 — ONLINE TDM Vancomycin Gen.3 (January 8, 2016)

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)

FDA data resources