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510(k) K792700

ASPERGILLUS SP, COMPLEMENT FIXATION by Meridian Diagnostics, Inc. — Product Code JWT

K792700 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "ASPERGILLUS SP, COMPLEMENT FIXATION". The FDA issued a decision of Substantially Equivalent on January 17, 1980. The device falls under product code JWT (Antigen, Cf, Aspergillus Spp.), a Class I device regulated under 21 CFR 866.3040. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1980
Date Received
December 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf, Aspergillus Spp.
Device Class
Class I
Regulation Number
866.3040
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 JWT

  • K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (October 20, 1981)
  • K791387 — ASPERGILLUS MYCELIAL ANTIGEN #CF10024X (August 16, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)
  • K760830 — ASPERGILLUS MYCELIAL ANTIGEN (November 1, 1976)

FDA data resources