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510(k) K011710

OXOID PBP2 1 LATEX AGGLUTINATION TEST by Oxoid , Ltd. — Product Code MYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2002
Date Received
June 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)
  • K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 2, 1999)

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  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)