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510(k) K813493

ENZYGNOST TM RUBELLA IGM by Calbiochem-Behring Corp. — Product Code LFX

K813493 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "ENZYGNOST TM RUBELLA IGM". The FDA issued a decision of Substantially Equivalent on March 4, 1982. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
December 14, 1981
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 Calbiochem-Behring Corp.

  • K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE (July 28, 1983)
  • K831036 — ENA TEST KIT SM & RNP AUTO ANTIBODY (April 27, 1983)
  • K830214 — AFT SYSTEM III (March 9, 1983)
  • K820812 — CREATINE KINASE-MB KIT (April 12, 1982)
  • K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM (January 26, 1982)
  • K812458 — PADAC (September 23, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)
  • K810404 — RHEUMATOID FACTORS REFERENCE SERUM (March 11, 1981)

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