Home / 510(k) Clearances / K823016

510(k) K823016

CANDIDA DETECTION SYSTEM by Ramco Laboratories, Inc. — Product Code LHK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1982
Date Received
October 12, 1982
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 Ramco Laboratories, Inc.

  • K983107 — VFE (October 22, 1998)
  • K981208 — TFR (October 21, 1998)
  • K910481 — EPO-RIA (November 29, 1991)
  • K872941 — SPECTRO C (September 4, 1987)
  • K864701 — VWF IMMUNOBLOT (March 30, 1987)
  • K861159 — SPECTRO VWF (May 1, 1986)
  • K831470 — PTH MR (June 22, 1983)
  • K812056 — SPECTRO FEIRITIN (August 12, 1981)

Other clearances for product code LHK

  • K893753 — DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST (October 16, 1989)
  • K812741 — REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (October 23, 1981)
  • K812186 — CANDIDA IMMUNODIFFUSION SYSTEM (August 25, 1981)