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510(k) K981867

IS-VZU IGG TEST SYSTEM by Diamedix Corp. — Product Code LFY

K981867 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "IS-VZU IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 1998. The device falls under product code LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Diamedix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1998
Date Received
May 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
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 LFY

  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K150375 — LIAISON VZV IgG, LIAISON Control VZV IgG (March 11, 2015)
  • K070317 — ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM (July 5, 2007)
  • K061820 — DIASORIN LIAISON VZV IGG (February 26, 2007)
  • K051484 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. (December 5, 2005)
  • K984181 — THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM (January 22, 1999)
  • K972295 — SERAQUEST VZV IGG (November 5, 1997)
  • K961012 — VZV IGG ELISA TEST SYSTEM (July 24, 1996)
  • K943843 — VARICELISA, MODIFICATION (March 14, 1996)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)

FDA data resources