Home / 510(k) Clearances / K132400

510(k) K132400

LP(A) CALIBRATORS, AND LP(A) CONTROLS by Biokit, S.A. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2013
Date Received
August 1, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Biokit, S.A.

  • K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Control (February 12, 2025)
  • K233605 — ADVIA Centaur EBV-EBNA IgG (August 7, 2024)
  • K233606 — ADVIA Centaur EBV-VCA IgM (August 7, 2024)
  • K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control (September 20, 2023)
  • K214068 — Quantia IgE (February 21, 2023)
  • K181334 — ADVIA Centaur Herpes-2 IgG (August 23, 2018)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K152185 — ARCHITECT SHBG (February 11, 2016)
  • K123947 — ARCHITECT IVANCOMYCIN (August 29, 2013)
  • K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D (November 23, 2011)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)