Home / 510(k) Clearances / K983420

510(k) K983420

THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO by Zeus Scientific, Inc. — Product Code LKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1998
Date Received
September 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Sm Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
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 LKP

  • K202067 — EliA SmDP-S (July 14, 2021)
  • K183007 — EliA SmDP Immunoassay (December 24, 2018)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP (April 17, 2013)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (January 15, 2003)
  • K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (July 29, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)