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510(k) K031490

RUBELLACOL by Immunostics Inc., — Product Code LQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2003
Date Received
May 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Latex Agglutination Assay, Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

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Other clearances for product code LQN

  • K970931 — COPALIS TORC TOTAL ANTIBODY ASSAY (April 24, 1997)
  • K961784 — COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSA (October 31, 1996)
  • K954920 — MUREX RUB-EX (August 21, 1996)
  • K952544 — COLORSLIDER RUBELLA (January 17, 1996)
  • K912391 — RUBALEX, MODIFICATION (May 4, 1992)
  • K901637 — RESUBMITTED MODIFIED RUBALEX (April 26, 1990)
  • K896433 — MODIFIED RUBAGEN (November 29, 1989)
  • K893755 — RUBAGEN (August 21, 1989)
  • K861881 — RUBALEX (REVISED VERSION) (June 4, 1986)
  • K852788 — RUBALEX (March 12, 1986)