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510(k) K823805

VARICELISA TEST KIT by M.A. Bioproducts — Product Code LFY

K823805 is an FDA 510(k) premarket notification submitted by M.A. Bioproducts for the device "VARICELISA TEST KIT". The FDA issued a decision of Substantially Equivalent on May 5, 1983. The device falls under product code LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. M.A. Bioproducts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1983
Date Received
December 17, 1982
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 M.A. Bioproducts

  • K822883 — HERPELISA KIT (July 26, 1983)
  • K823804 — MYCOPLASMELISA TEST KIT (May 25, 1983)
  • K830045 — MUMPSELISA TEST KIT (May 13, 1983)
  • K830615 — CYTOMEGELISA STAT (May 9, 1983)
  • K821967 — CHLAMYDELISA TEST KIT (August 3, 1982)
  • K821762 — MEASELISA TEST KIT (July 30, 1982)
  • K813221 — TOXOELISA TEST KIT (January 26, 1982)
  • K812531 — CELL CULTURE REAGENTS (October 23, 1981)
  • K812123 — CYTOMEGELISA TEST KIT (September 23, 1981)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)

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)
  • K981867 — IS-VZU IGG TEST SYSTEM (September 28, 1998)
  • K972295 — SERAQUEST VZV IGG (November 5, 1997)
  • K961012 — VZV IGG ELISA TEST SYSTEM (July 24, 1996)
  • K943843 — VARICELISA, MODIFICATION (March 14, 1996)

FDA data resources