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510(k) K812186

CANDIDA IMMUNODIFFUSION SYSTEM by American Scientific Products — Product Code LHK

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, Id, Candida Albicans
Device Class
Class II
Regulation Number
866.3165
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 LHK

  • K893753 — DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST (October 16, 1989)
  • K823016 — CANDIDA DETECTION SYSTEM (December 28, 1982)
  • K812741 — REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (October 23, 1981)