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510(k) K080012

PLATELIA LYME IGG ASSAY by Bio-Rad — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2008
Date Received
January 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Bio-Rad

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  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)
  • K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (November 9, 2005)

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