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510(k) K812741

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS by Nolan Biological Laboratories, Inc. — Product Code LHK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1981
Date Received
September 29, 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 Nolan Biological Laboratories, Inc.

  • K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (October 20, 1981)
  • K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM (September 26, 1980)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K802128 — IMMUNODIFFUSSION REAGENTS/SEROLOGICAL (September 26, 1980)

Other clearances for product code LHK

  • K893753 — DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST (October 16, 1989)
  • K823016 — CANDIDA DETECTION SYSTEM (December 28, 1982)
  • K812186 — CANDIDA IMMUNODIFFUSION SYSTEM (August 25, 1981)