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510(k) K790672

ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU by Diagnostica, Inc. — Product Code JWT

K790672 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU". The FDA issued a decision of Substantially Equivalent on May 31, 1979. The device falls under product code JWT (Antigen, Cf, Aspergillus Spp.), a Class I device regulated under 21 CFR 866.3040. Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1979
Date Received
April 6, 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 Diagnostica, Inc.

  • K002756 — EASE-A-CULT (February 23, 2001)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT (March 12, 1980)
  • K791281 — ANTI-HUMAN IGG SERUM (November 27, 1979)
  • K791284 — ANTI-HUMAN KAPPA SERUM (November 27, 1979)
  • K791283 — ANTI-HUMAN LAMBDA SERUM (November 27, 1979)
  • K791285 — ANTI-HUMAN GLOBULINS (October 17, 1979)
  • K791282 — ANTI-HUMAN SERUM (October 17, 1979)
  • K790671 — DERMATOPHYTIN O (May 31, 1979)

Other clearances for product code JWT

  • K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (October 20, 1981)
  • K792700 — ASPERGILLUS SP, COMPLEMENT FIXATION (January 17, 1980)
  • K791387 — ASPERGILLUS MYCELIAL ANTIGEN #CF10024X (August 16, 1979)
  • K760830 — ASPERGILLUS MYCELIAL ANTIGEN (November 1, 1976)

FDA data resources