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510(k) K760830

ASPERGILLUS MYCELIAL ANTIGEN by I M, Inc. — Product Code JWT

K760830 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "ASPERGILLUS MYCELIAL ANTIGEN". The FDA issued a decision of Substantially Equivalent on November 1, 1976. The device falls under product code JWT (Antigen, Cf, Aspergillus Spp.), a Class I device regulated under 21 CFR 866.3040. I M, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1976
Date Received
October 13, 1976
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 I M, Inc.

  • K914600 — NEUROLOGICAL SPONGE (December 30, 1992)
  • K892389 — BIOPSY KIT (July 17, 1989)
  • K881363 — SYRINGE PREFILLED WITH WATER (June 23, 1988)
  • K880753 — UMBILICAL CORD CLAMP (April 27, 1988)
  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)

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)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)

FDA data resources