Home / 510(k) Clearances / K984181

510(k) K984181

THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM by Zeus Scientific, Inc. — Product Code LFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1999
Date Received
November 23, 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 Zeus Scientific, Inc.

  • K250666 — Alegria Flash CTD Screen (October 22, 2025)
  • K250408 — Alegria Flash ENA Screen (September 19, 2025)
  • K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplas (May 7, 2025)
  • K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine (August 31, 2023)
  • K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia Vl (July 13, 2023)
  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (July 26, 2012)

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)
  • 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)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)