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510(k) K760833

ANTI-BLASTOMYCES CONTROL SERUM (YEAST) by I M, Inc. — Product Code KFH

K760833 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "ANTI-BLASTOMYCES CONTROL SERUM (YEAST)". The FDA issued a decision of Substantially Equivalent on November 1, 1976. The device falls under product code KFH (Antiserum, Positive Control, Blastomyces Dermatitidis), a Class II device regulated under 21 CFR 866.3060. 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, Blastomyces Dermatitidis
Device Class
Class II
Regulation Number
866.3060
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 KFH

  • K880029 — EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 (February 24, 1988)
  • K792681 — BLASTOMYCES DERMATITIDIS POS/CONTROL (January 17, 1980)
  • K792685 — BLASTOMYCES DERMATITIDIS, ANTISERUM (January 17, 1980)

FDA data resources