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510(k) K812185

FUNGAL IMMUNODIFFUSION SYSTEM by American Scientific Products — Product Code GMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1981
Date Received
August 3, 1981
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

Other clearances by American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

Other clearances for product code GMI

  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 1989)
  • K812190 — COCCIDIOIDES IMMUNODIFFUSION SYSTEM (August 31, 1981)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K792716 — CANDIDA ALBICANS, ANTIGEN (January 24, 1980)
  • K792713 — CANDIDA ALBICANS, ANTISERUM (January 23, 1980)
  • K792682 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K792689 — 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)