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510(k) K871832

CMV IGM MICROASSAY by Diamedix Corp. — Product Code LKQ

K871832 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "CMV IGM MICROASSAY". The FDA issued a decision of Substantially Equivalent on August 7, 1987. The device falls under product code LKQ (Antibody Igm,If, Cytomegalovirus Virus), a Class II device regulated under 21 CFR 866.3175. Diamedix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1987
Date Received
May 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm,If, Cytomegalovirus Virus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Diamedix Corp.

  • K093101 — MAGO 4S (January 21, 2011)
  • K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (July 9, 2002)
  • K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (January 8, 2002)
  • K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (December 21, 2001)
  • K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (October 26, 2001)
  • K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (October 26, 2001)
  • K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (September 28, 2001)
  • K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (September 28, 2001)
  • K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (August 20, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)

Other clearances for product code LKQ

  • K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUS (May 13, 2010)
  • K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
  • K933549 — VIDAS CMV IGM ASSAY (August 2, 1994)
  • K922580 — BARTELS CYTOMEGALOVIRUS IGM EIA (April 8, 1993)
  • K914789 — ELISA CMV IGM (March 4, 1992)
  • K913080 — OPUS(R) ANTI CMV-M (October 28, 1991)
  • K900743 — CMV-IGM IFA TEST SYSTEM (April 26, 1990)
  • K893465 — CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (July 25, 1989)
  • K893466 — CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (July 14, 1989)
  • K872881 — ABBOTT CMV-M EIA KIT (May 13, 1988)

FDA data resources