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510(k) K011710

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

K011710 is an FDA 510(k) premarket notification submitted by Oxoid , Ltd. for the device "OXOID PBP2 1 LATEX AGGLUTINATION TEST". The FDA issued a decision of Substantially Equivalent on April 2, 2002. The device falls under product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies), a Class II device regulated under 21 CFR 866.1640. Oxoid , Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by Oxoid , Ltd.

  • K070262 — ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (March 14, 2007)
  • K060286 — TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (March 17, 2006)
  • K042157 — DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (September 14, 2004)
  • K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M (December 10, 2001)
  • K010536 — MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K010537 — LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K000930 — GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 22, 2000)
  • K000928 — QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 15, 2000)
  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)
  • K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 2, 1999)

Other clearances for product code MYI

  • K140619 — MECA XPRESSFISH (October 10, 2014)
  • K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TEST (September 3, 2014)
  • K121905 — ALERE PBP2A TEST (July 26, 2012)
  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (February 24, 2010)
  • K062864 — MASTALEX -MRSA, MODEL RST501 (October 18, 2006)
  • K011400 — MRSA-SCREEN (March 27, 2002)
  • K010858 — VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (May 24, 2001)
  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)

FDA data resources