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510(k) K101089

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR by Medica Corp. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2011
Date Received
April 19, 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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  • K101203 — TINA-QUANT ALBUMIN GEN 2 (September 10, 2010)
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  • 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)