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510(k) K803133

RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL by Microbiological Research Corp. — Product Code LFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1981
Date Received
December 12, 1980
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 Microbiological Research Corp.

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  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K860450 — THE CMV-IGM TEST (May 13, 1986)
  • K843138 — CMV TEST (January 29, 1985)
  • K821018 — ANTIHUMAN IGG GLOBULIN FITC LABELED (April 29, 1982)
  • K821019 — PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (April 26, 1982)
  • K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS (January 29, 1981)

Other clearances for product code LFX

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  • 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)