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510(k) K971663

WELLCOLEX E.COLI O157:H7 by Murex Biotech , Ltd. — Product Code GMZ

K971663 is an FDA 510(k) premarket notification submitted by Murex Biotech , Ltd. for the device "WELLCOLEX E.COLI O157:H7". The FDA issued a decision of Substantially Equivalent on December 30, 1997. 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 30, 1997
Date Received
May 6, 1997
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

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  • K121364 — SHIGA TOXIN QUIK CHEK (October 2, 2012)
  • K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630 (February 14, 2007)
  • K061889 — BIOSTAR OIA SHIGATOX (December 12, 2006)
  • 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)
  • K972156 — QUIX RAPID E. COLI O157 STRIP TEST (October 16, 1997)

FDA data resources