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510(k) K071799

MODIFICATION TO BIOSTAR OIA SHIGATOX by Iverness Medical Professional Diagnostics — Product Code GNA

K071799 is an FDA 510(k) premarket notification submitted by Iverness Medical Professional Diagnostics for the device "MODIFICATION TO BIOSTAR OIA SHIGATOX". The FDA issued a decision of Substantially Equivalent on October 2, 2007. The device falls under product code GNA (Antisera, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2007
Date Received
July 2, 2007
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 for product code GNA

  • 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)
  • K884026 — ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (February 3, 1989)
  • K874288 — PHADEBACT ETEC-LT TEST (September 2, 1988)

FDA data resources