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510(k) K792688

COCCIDIOIDES IMMITIS, ANTISERUM by Meridian Diagnostics, Inc. — Product Code GMH

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

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Other clearances for product code GMH

  • K792684 — COCCIDIOIDES IMMITIS, ANTISERUM, (January 17, 1980)
  • K792717 — COCCIDIOIDES IMMITIS, ANTISERUM POS. (January 17, 1980)
  • K791388 — ANTI-COCCIDIOIDES SERUM #CF10028X (August 16, 1979)
  • K760834 — ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) (November 1, 1976)