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510(k) K792679

HISTOPLASMA CAPSULATUM, ANTISERUM by Meridian Diagnostics, Inc. — Product Code GMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1980
Date Received
December 27, 1979
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

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Other clearances for product code GMK

  • K792692 — IMMUNODIFFUSION BAND INTENSIFYING FLUID (January 24, 1980)
  • K792694 — NEGATIVE CONTROL SERUM (January 24, 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)
  • K760831 — ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) (November 1, 1976)