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510(k) K933794

ANI BIOCARD(TM) HCG TEST by Canadian Bioclinical, Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1994
Date Received
August 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Canadian Bioclinical, Ltd.

  • K870968 — TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (June 22, 1987)
  • K870969 — CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (June 22, 1987)
  • K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (February 2, 1987)

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