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510(k) K182095

Tina-quant Transferrin ver.2 (urine application) by Roche Diagnostics Operations (Rdo) — Product Code DDG

K182095 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "Tina-quant Transferrin ver.2 (urine application)". The FDA issued a decision of Substantially Equivalent on November 5, 2018. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2018
Date Received
August 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
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)
  • 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)
  • K151578 — Carbamazepine Gen 4 (October 22, 2015)

Other clearances for product code DDG

  • K240987 — Access sTfR (July 3, 2024)
  • K190495 — Transferrin (March 16, 2020)
  • K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS (February 13, 2013)
  • K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A3 (August 11, 2008)
  • K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (August 8, 2008)
  • K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (August 8, 2007)
  • K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- (April 23, 2007)
  • K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (March 21, 2007)
  • K063322 — DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTR (January 24, 2007)
  • K053075 — N ANTISERA TO HUMAN TRANSFERRIN (March 16, 2006)

FDA data resources