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510(k) K961784

COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS by Sienna Biotech, Inc. — Product Code LQN

K961784 is an FDA 510(k) premarket notification submitted by Sienna Biotech, Inc. for the device "COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS". The FDA issued a decision of Substantially Equivalent on October 31, 1996. The device falls under product code LQN (Latex Agglutination Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Sienna Biotech, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1996
Date Received
May 2, 1996
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 Sienna Biotech, Inc.

  • K970931 — COPALIS TORC TOTAL ANTIBODY ASSAY (April 24, 1997)
  • K955799 — COPALIS CMV TOTAL ANTIBODY ASSAY (July 10, 1996)

Other clearances for product code LQN

  • K031490 — RUBELLACOL (July 16, 2003)
  • K970931 — COPALIS TORC TOTAL ANTIBODY ASSAY (April 24, 1997)
  • 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)

FDA data resources