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510(k) K915700

PERMIER HISTOPLASMA by Meridian Diagnostics, Inc. — Product Code MIZ

K915700 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "PERMIER HISTOPLASMA". The FDA issued a decision of Substantially Equivalent on July 30, 1992. The device falls under product code MIZ (Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum), a Class II device regulated under 21 CFR 866.3320. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
December 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Device Class
Class II
Regulation Number
866.3320
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)
  • K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (June 25, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 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 MIZ

  • K101407 — ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 (July 19, 2011)

FDA data resources