OXOID PBP2 1 LATEX AGGLUTINATION TEST— 510(k) K011710

Name: FDA 510(k) clearance K011710
Creator: U.S. Food and Drug Administration
Published: 2002-04-02

Substantially Equivalent

Oxoid , Ltd.

FDA 510(k) clearance K011710 for OXOID PBP2 1 LATEX AGGLUTINATION TEST, Substantially Equivalent on 2002-04-02. Applicant: Oxoid , Ltd.. Device class: 2.

Clearance details

Applicant: Oxoid , Ltd.
Product code: Code MYI
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2001-06-04
Decision date: 2002-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code MYI

view all

K140619 — MECA XPRESSFISH2014-10-10
K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TEST2014-09-03
K121905 — ALERE PBP2A TEST2012-07-26
K090301 — BINAXNOW PBP2A TEST, MODEL 890-0002010-04-14
K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-0002010-02-24

More clearances from Oxoid , Ltd.

view all

K070262 — ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2007-03-14
K060286 — TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2006-03-17
K042157 — DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2004-09-14
K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M2001-12-10
K010536 — MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2001-04-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.