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510(k) K924493

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD by Casco Standards — Product Code JJX

K924493 is an FDA 510(k) premarket notification submitted by Casco Standards for the device "DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD". The FDA issued a decision of Substantially Equivalent on January 11, 1993. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Casco Standards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1993
Date Received
August 28, 1992
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 Casco Standards

  • K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 (April 24, 1998)
  • K972904 — DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (February 20, 1998)
  • K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR (September 13, 1996)
  • K961750 — DOCUMENT CARDIAC ASSAYED CONTROL (July 22, 1996)
  • K962630 — DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (July 22, 1996)
  • K960244 — DOCUMENT TDM ULTRA ASSAYED CONTROL (March 22, 1996)
  • K955155 — DOCUMENT TDM ULTRA UNASSAYED CONTROL (December 20, 1995)
  • K950469 — DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (April 11, 1995)
  • K945718 — DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (January 17, 1995)
  • K945315 — DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL (December 9, 1994)

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