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510(k) K001767

DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM by Diamedix Corp. — Product Code LJO

K001767 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 2000. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), 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, 2000
Date Received
June 12, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Iha, Cytomegalovirus
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)
  • K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (October 26, 2001)
  • K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA 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 LJO

  • K203612 — Capture-CMV (March 22, 2021)
  • K183571 — Capture-CMV (February 4, 2019)
  • K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY (September 29, 1998)
  • K974456 — CMVGEN (May 1, 1998)
  • K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (July 24, 1996)
  • K955799 — COPALIS CMV TOTAL ANTIBODY ASSAY (July 10, 1996)
  • K920222 — HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (July 27, 1992)
  • K910003 — CYTOMEGALOVIRUS ANTIBODY SCREEN (March 20, 1991)
  • K852494 — CMV-IHA (September 16, 1985)
  • K841520 — CMV LATEX AGGLUTINATION TEST KIT (September 7, 1984)

FDA data resources