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510(k) K952544

COLORSLIDER RUBELLA by Seradyn, Inc. — Product Code LQN

K952544 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "COLORSLIDER RUBELLA". The FDA issued a decision of Substantially Equivalent on January 17, 1996. The device falls under product code LQN (Latex Agglutination Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Seradyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1996
Date Received
June 2, 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 Seradyn, Inc.

  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 2007)
  • K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (January 12, 2007)
  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K060709 — MULTIGENT GENTAMICIN (June 15, 2006)
  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 2005)
  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (November 3, 2004)

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)
  • K954920 — MUREX RUB-EX (August 21, 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