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510(k) K760832

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

K760832 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "ANTI-HISTOPLASMA CONTROL SERUM (YEAST)". The FDA issued a decision of Substantially Equivalent on November 1, 1976. The device falls under product code GMK (Antiserum, Positive Control, Histoplasma Capsulatum), a Class II device regulated under 21 CFR 866.3320. 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, Histoplasma Capsulatum
Device Class
Class II
Regulation Number
866.3320
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 GMK

  • K792692 — IMMUNODIFFUSION BAND INTENSIFYING FLUID (January 24, 1980)
  • K792694 — NEGATIVE CONTROL SERUM (January 24, 1980)
  • K792679 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K792718 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K791395 — ANTI-HISTOPLASMA SERUM #CF10025X (August 16, 1979)
  • K791392 — ANTI-HISTOPLASMA SERUM #CF10026X (August 16, 1979)
  • K791390 — ANTI-BLASTOMYCES SERUM #CF10027X (August 16, 1979)
  • K760831 — ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) (November 1, 1976)

FDA data resources