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510(k) K863499

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

K863499 is an FDA 510(k) premarket notification submitted by Mercia Diagnostics , Ltd. for the device "CANDIDATE(R) SUPER". The FDA issued a decision of Substantially Equivalent on March 19, 1987. The device falls under product code LRF (Candida Spp., Direct Antigen, Id), a Class II device regulated under 21 CFR 866.3165. Mercia Diagnostics , Ltd. has at least 10 other 510(k) clearances on record.

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)
  • K896295 — CAPTIA(R) CMV-M (March 6, 1990)
  • K900655 — MODIFIED CAPTIA(R) TOXO-M (March 6, 1990)
  • K896194 — CAPTIA(R) CMV-G (March 6, 1990)
  • K883924 — CAPTIA(R) RUBELLA-G (August 15, 1989)
  • K885300 — CAPTIA(R) RUBELLA-M (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)

FDA data resources