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510(k) K101203

TINA-QUANT ALBUMIN GEN 2 by Roche Diagnostics — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2010
Date Received
April 29, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

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Other clearances for product code DCF

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  • K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (July 13, 2011)
  • K100853 — COBAS 8000 MODULAR SERIES ANALYZER (September 9, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (April 8, 2009)
  • K061990 — DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTE (September 19, 2006)