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510(k) K904393

PREMIER-CRYPTOCOCCAL ANTIGEN by Meridian Diagnostics, Inc. — Product Code MDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1991
Date Received
September 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Elisa, Cryptococcus
Device Class
Class II
Regulation Number
866.3165
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 MDU

  • K120946 — ALPHA CRYPTOCOCCAL ANTIGEN EIA (December 17, 2012)