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510(k) K760831

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

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.

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  • K892389 — BIOPSY KIT (July 17, 1989)
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  • 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

  • K792694 — NEGATIVE CONTROL SERUM (January 24, 1980)
  • K792692 — IMMUNODIFFUSION BAND INTENSIFYING FLUID (January 24, 1980)
  • K792679 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K792718 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K791390 — ANTI-BLASTOMYCES SERUM #CF10027X (August 16, 1979)
  • K791392 — ANTI-HISTOPLASMA SERUM #CF10026X (August 16, 1979)
  • K791395 — ANTI-HISTOPLASMA SERUM #CF10025X (August 16, 1979)
  • K760832 — ANTI-HISTOPLASMA CONTROL SERUM (YEAST) (November 1, 1976)