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510(k) K904524

CAPTIA(R) SYPHILIS M, MODIFICATION by Mercia Diagnostics , Ltd. — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1990
Date Received
September 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Mercia Diagnostics , Ltd.

  • K915479 — CAPTIA CMV-TA (May 4, 1992)
  • 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)
  • 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)
  • K880918 — CAPTIA TOXO-G (August 1, 1988)

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  • K102400 — SYPHILIS HEALTH CHECK (August 1, 2011)