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510(k) K894617

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL by Schiff & Co. — Product Code GMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf And / Or Id, Coccidioides Immitis
Device Class
Class II
Regulation Number
866.3135
Review Panel
MI
Submission Type

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Other clearances for product code GMI

  • K812190 — COCCIDIOIDES IMMUNODIFFUSION SYSTEM (August 31, 1981)
  • K812185 — FUNGAL IMMUNODIFFUSION SYSTEM (August 25, 1981)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K792716 — CANDIDA ALBICANS, ANTIGEN (January 24, 1980)
  • K792713 — CANDIDA ALBICANS, ANTISERUM (January 23, 1980)
  • K792689 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K792682 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K791383 — CANDIDA IMMUNODIFFUSION KIT #CA1001 (August 16, 1979)
  • K791389 — COCCIDIOIDES ANTIGEN #CF10023X (August 16, 1979)
  • K770527 — CANDIDA IMMUNODIFFUSION KIT (March 17, 1978)