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510(k) K954920

MUREX RUB-EX by Murex Diagnostics, Inc. — Product Code LQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1996
Date Received
October 26, 1995
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

Other clearances by Murex Diagnostics, Inc.

  • K962028 — WELLCOLEX E-COLI OI57 ZC60 (November 1, 1996)

Other clearances for product code LQN

  • K031490 — RUBELLACOL (July 16, 2003)
  • K970931 — COPALIS TORC TOTAL ANTIBODY ASSAY (April 24, 1997)
  • K961784 — COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSA (October 31, 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)