Home / 510(k) Clearances / K061889

510(k) K061889

BIOSTAR OIA SHIGATOX by Inverness Medical-Biostar, Inc. — Product Code GMZ

K061889 is an FDA 510(k) premarket notification submitted by Inverness Medical-Biostar, Inc. for the device "BIOSTAR OIA SHIGATOX". The FDA issued a decision of Substantially Equivalent on December 12, 2006. The device falls under product code GMZ (Antigens, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2006
Date Received
July 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Types, Escherichia Coli
Device Class
Class I
Regulation Number
866.3255
Review Panel
MI
Submission Type

Other clearances for product code GMZ

  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K121411 — SHIGA TOXIN CHEK (October 2, 2012)
  • K121364 — SHIGA TOXIN QUIK CHEK (October 2, 2012)
  • K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630 (February 14, 2007)
  • K023599 — IMMUNOCARD STAT! E. COLI O157 PLUS (January 3, 2003)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAY (April 23, 1998)
  • K973457 — CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (January 2, 1998)
  • K971663 — WELLCOLEX E.COLI O157:H7 (December 30, 1997)
  • K972156 — QUIX RAPID E. COLI O157 STRIP TEST (October 16, 1997)

FDA data resources