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510(k) K153560

Optilite Low Level Albumin Kit by The Binding Site Group , Ltd. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2016
Date Received
December 14, 2015
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)
  • K101203 — TINA-QUANT ALBUMIN GEN 2 (September 10, 2010)
  • 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)