Home / 510(k) Clearances / K833637

510(k) K833637

VZV BIO-ENZABEAD SCREEN KIT by Bionetic Laboratory Products — Product Code LFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1984
Date Received
October 17, 1983
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 Bionetic Laboratory Products

  • K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (November 14, 1983)
  • K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT (September 26, 1983)
  • K831760 — LEGIONELLA IFA KIT I (August 8, 1983)
  • K830820 — LEGIONELLA DFA KIT I (June 8, 1983)
  • K831133 — AMEBIASIS BIO-ENZABEAD SCREEN KIT (June 8, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)

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)