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510(k) K912391

RUBALEX, MODIFICATION by Orion Corp. — Product Code LQN

K912391 is an FDA 510(k) premarket notification submitted by Orion Corp. for the device "RUBALEX, MODIFICATION". The FDA issued a decision of Substantially Equivalent on May 4, 1992. The device falls under product code LQN (Latex Agglutination Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Orion Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1992
Date Received
May 24, 1991
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 Orion Corp.

  • K901637 — RESUBMITTED MODIFIED RUBALEX (April 26, 1990)
  • K884650 — RESUBMITTED SCANORA (March 16, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K881506 — MAMEX DC MAG MG12 (June 10, 1988)
  • K881505 — MAMEX DC MG11 (June 10, 1988)
  • K874040 — MAMEX DC S SL10/MG14 (November 23, 1987)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K864457 — CHLAMYSET ANTIBODY EIA (September 11, 1987)
  • K872301 — DENTOCULT-SM CULTURE-PADDLE (September 11, 1987)
  • K872058 — ORICULT-N CULTURE-PADDLE (June 10, 1987)

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)
  • K952544 — COLORSLIDER RUBELLA (January 17, 1996)
  • 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