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510(k) K792686

ASPERGILLUS SP, ANTISERUM POSITIVE by Meridian Diagnostics, Inc. — Product Code KFG

K792686 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "ASPERGILLUS SP, ANTISERUM POSITIVE". The FDA issued a decision of Substantially Equivalent on January 17, 1980. The device falls under product code KFG (Antiserum, Positive Control, 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
Antiserum, Positive Control, 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 KFG

  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)
  • K792698 — ASPERGILLUS SP, ANTISERUM, POSITIVE (January 17, 1980)
  • K791386 — ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM (August 16, 1979)
  • K760835 — ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) (November 1, 1976)

FDA data resources