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510(k) K884247

MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT by Disease Detection International, Inc. — Product Code LFX

K884247 is an FDA 510(k) premarket notification submitted by Disease Detection International, Inc. for the device "MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Disease Detection International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1989
Date Received
October 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

Other clearances by Disease Detection International, Inc.

  • K943252 — PRO-STEP LH OVULATION PREDICTION TEST (October 25, 1994)
  • K925303 — PRO-STEP PT HCG (June 15, 1993)
  • K925125 — PRO-STEP HCG (January 13, 1993)
  • K911826 — IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (July 19, 1991)
  • K902571 — MODIFICATION OF SEROCARD RUBELLA IGG TEST (September 5, 1990)
  • K903070 — SEROCARD HSV IGG ANTIBODY TEST KIT (August 9, 1990)
  • K895912 — IMMUNOCARD HCG II-S TEST KIT (December 1, 1989)
  • K896109 — IMMUNOCARD STREP A TEST (November 29, 1989)
  • K884246 — MODIFIED DDI SEROCARD HERPES IGG TEST KIT (April 10, 1989)
  • K884249 — MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT (April 10, 1989)

Other clearances for product code LFX

  • K250588 — Access Rubella IgG (November 17, 2025)
  • K243168 — Alinity i Rubella IgG (June 20, 2025)
  • K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (September 6, 2012)
  • K093101 — MAGO 4S (January 21, 2011)
  • K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION S (December 3, 2010)
  • K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY (March 12, 2010)
  • K080766 — VIDAS RUB IGG (December 23, 2008)
  • K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY (December 5, 2008)
  • K073390 — DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS (November 21, 2008)
  • K063186 — ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (March 21, 2007)

FDA data resources