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510(k) K873299

MERIFLUOR(TM)-GIARDIA by Meridian Diagnostics, Inc. — Product Code GWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1987
Date Received
August 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Device Class
Class II
Regulation Number
866.3220
Review Panel
MI
Submission Type

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  • K980076 — PREMIER PLATINUM HPSA (May 12, 1998)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)

Other clearances for product code GWD

  • K844836 — HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER (January 23, 1985)