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510(k) K993401

DRYSPOT E.COLI 0157 KIT by Oxoid , Ltd. — Product Code GNA

K993401 is an FDA 510(k) premarket notification submitted by Oxoid , Ltd. for the device "DRYSPOT E.COLI 0157 KIT". The FDA issued a decision of Substantially Equivalent on February 28, 2000. The device falls under product code GNA (Antisera, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Oxoid , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2000
Date Received
October 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Escherichia Coli
Device Class
Class I
Regulation Number
866.3255
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)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • 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)
  • K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 2, 1999)

Other clearances for product code GNA

  • K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOX (October 2, 2007)
  • K031367 — DUOPATH VEROTOXINS GLISA TEST (January 23, 2004)
  • K981734 — VTEC-RPLA SEIKEN (September 22, 1998)
  • K962028 — WELLCOLEX E-COLI OI57 ZC60 (November 1, 1996)
  • K953362 — PREMIER EHEC (November 14, 1995)
  • K950167 — PREMIER EHEC (April 14, 1995)
  • K933457 — RIM E.COLI 0157:H7 LATEX TEST (April 20, 1994)
  • K903714 — E. COLI 0157 LATEX TEST (January 24, 1991)
  • K884026 — ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (February 3, 1989)
  • K874288 — PHADEBACT ETEC-LT TEST (September 2, 1988)

FDA data resources