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510(k) K863499

CANDIDATE(R) SUPER by Mercia Diagnostics , Ltd. — Product Code LRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1987
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Candida Spp., Direct Antigen, Id
Device Class
Class II
Regulation Number
866.3165
Review Panel
MI
Submission Type

Other clearances by Mercia Diagnostics , Ltd.

  • K915479 — CAPTIA CMV-TA (May 4, 1992)
  • K904524 — CAPTIA(R) SYPHILIS M, MODIFICATION (December 26, 1990)
  • K900654 — MODIFIED CAPTIA(R) SYPHILIS-M (March 8, 1990)
  • K896194 — CAPTIA(R) CMV-G (March 6, 1990)
  • K896295 — CAPTIA(R) CMV-M (March 6, 1990)
  • K900655 — MODIFIED CAPTIA(R) TOXO-M (March 6, 1990)
  • K885300 — CAPTIA(R) RUBELLA-M (August 15, 1989)
  • K883924 — CAPTIA(R) RUBELLA-G (August 15, 1989)
  • K892802 — SUPER DUO (June 13, 1989)
  • K881425 — CAPTIA(R) SYPHILIS-G (August 4, 1988)

Other clearances for product code LRF

  • K883118 — ON THE SPOT CANDIDASURE (September 30, 1988)
  • K843286 — EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (October 1, 1984)