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510(k) K792690

COCCIDIOIDES IMMITIS, LATEX AGGLUTI by Meridian Diagnostics, Inc. — Product Code GMG

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
Antigen, Latex Agglutination, Coccidioides Immitis
Device Class
Class II
Regulation Number
866.3135
Review Panel
MI
Submission Type

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Other clearances for product code GMG

  • K812189 — COCCIDIOIDES LATEX AGGLUTINATION (August 25, 1981)
  • K791381 — COCCIDIODES (COCCI) (August 16, 1979)
  • K782070 — REAGENT, COCCI LATEX (February 1, 1979)
  • K760829 — COCCIDIOIDES MYCELIAL ANTIGEN (November 1, 1976)