DRYSPOT E.COLI 0157 KIT— 510(k) K993401

Substantially Equivalent

Oxoid , Ltd.

FDA 510(k) clearance K993401 for DRYSPOT E.COLI 0157 KIT, Substantially Equivalent on 2000-02-28. Applicant: Oxoid , Ltd.. Device class: 1.

Clearance details

Applicant: Oxoid , Ltd.
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1999-10-08
Decision date: 2000-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNA

K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOX2007-10-02
K031367 — DUOPATH VEROTOXINS GLISA TEST2004-01-23
K981734 — VTEC-RPLA SEIKEN1998-09-22
K962028 — WELLCOLEX E-COLI OI57 ZC601996-11-01
K953362 — PREMIER EHEC1995-11-14

More clearances from Oxoid , Ltd.

K070262 — ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2007-03-14
K060286 — TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2006-03-17
K042157 — DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2004-09-14
K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST2002-04-02
K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M2001-12-10

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