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510(k) K060027

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) by Biokit, S.A. — Product Code JJX

K060027 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)". The FDA issued a decision of Substantially Equivalent on January 26, 2006. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Biokit, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2006
Date Received
January 4, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
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)
  • K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS (December 19, 2013)
  • K123947 — ARCHITECT IVANCOMYCIN (August 29, 2013)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources