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510(k) K933457

RIM E.COLI 0157:H7 LATEX TEST by Remel Co. — Product Code GNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1994
Date Received
July 14, 1993
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

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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)
  • 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)