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510(k) K904393

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

K904393 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "PREMIER-CRYPTOCOCCAL ANTIGEN". The FDA issued a decision of Substantially Equivalent on January 25, 1991. The device falls under product code MDU (Antigen, Elisa, Cryptococcus), a Class II device regulated under 21 CFR 866.3165. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Meridian Diagnostics, Inc.

  • K993914 — PREMIER TOXINS A&B, MODEL 616096 (December 10, 1999)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (June 25, 1999)
  • K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA (December 17, 1998)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • 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)

FDA data resources