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510(k) K884026

ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT by Oxoid U.S.A., Inc. — Product Code GNA

K884026 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code GNA (Antisera, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
September 23, 1988
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 U.S.A., Inc.

  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K874303 — STAPHYLASE TEST (November 6, 1987)
  • K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 813 (August 10, 1987)
  • K872135 — MCBRIDE MEDIUM CM 819 (June 15, 1987)
  • K870945 — RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (June 10, 1987)
  • K862946 — OXOID SIGNAL BLOOD CULTURE SYSTEM (November 5, 1986)
  • K855236 — DIAGNOSTIC REAGENT TST-RPLA (November 4, 1986)
  • K855233 — DIAGNOSTIC REAGENT SET-RPLA (November 4, 1986)
  • K855235 — DIAGNOSTIC REAGENT PET-RPLA (November 4, 1986)

Other clearances for product code GNA

  • K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOX (October 2, 2007)
  • K031367 — DUOPATH VEROTOXINS GLISA TEST (January 23, 2004)
  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)
  • 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)
  • K874288 — PHADEBACT ETEC-LT TEST (September 2, 1988)

FDA data resources