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510(k) K962028

WELLCOLEX E-COLI OI57 ZC60 by Murex Diagnostics, Inc. — Product Code GNA

K962028 is an FDA 510(k) premarket notification submitted by Murex Diagnostics, Inc. for the device "WELLCOLEX E-COLI OI57 ZC60". The FDA issued a decision of Substantially Equivalent on November 1, 1996. The device falls under product code GNA (Antisera, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Murex Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1996
Date Received
May 23, 1996
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 Murex Diagnostics, Inc.

  • K954920 — MUREX RUB-EX (August 21, 1996)

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)
  • 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