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510(k) K042448

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT by General Atomics — Product Code JJX

K042448 is an FDA 510(k) premarket notification submitted by General Atomics for the device "DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT". The FDA issued a decision of Substantially Equivalent on October 29, 2004. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. General Atomics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2004
Date Received
September 9, 2004
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 General Atomics

  • K082488 — DIAZYME LP(A) ASSAY (January 13, 2009)
  • K072977 — DIAZYME APOLIPOPROTEIN A-1 ASSAY (July 16, 2008)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050178 — HBA1C ENZYMATIC ASSAY (June 28, 2005)
  • K033360 — DIAZYME LITHIUM ENZYMATIC ASSAY KIT (December 23, 2003)

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