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510(k) K760835

ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) by I M, Inc. — Product Code KFG

K760835 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)". The FDA issued a decision of Substantially Equivalent on November 1, 1976. The device falls under product code KFG (Antiserum, Positive Control, 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
Antiserum, Positive Control, 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 KFG

  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)
  • K792686 — ASPERGILLUS SP, ANTISERUM POSITIVE (January 17, 1980)
  • K792698 — ASPERGILLUS SP, ANTISERUM, POSITIVE (January 17, 1980)
  • K791386 — ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM (August 16, 1979)

FDA data resources