Home / 510(k) Clearances / K983617

510(k) K983617

25-HYDROXYVITAMIN D 125I RIA KIT by DiaSorin, Inc. — Product Code LCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1998
Date Received
October 15, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Radioimmunoassay Systems, For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by DiaSorin, Inc.

  • DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (December 23, 2025)
  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set (July 14, 2022)
  • K193650 — LIAISON Ferritin (September 14, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)
  • K201908 — LIAISON Testosterone xt (October 15, 2020)

Other clearances for product code LCI

  • K801037 — CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA (May 28, 1980)
  • K780886 — SYSTEM 6000 AUTOMATED RIA ANALYZER (September 1, 1978)