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510(k) K972287

DADE TRU-LIQUID BILIRUBIN CONTROL by Dade Intl., Inc. — Product Code JJX

K972287 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "DADE TRU-LIQUID BILIRUBIN CONTROL". The FDA issued a decision of Substantially Equivalent on July 7, 1997. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1997
Date Received
June 19, 1997
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 Dade Intl., Inc.

  • K974343 — DADE INNOVIN (July 22, 1998)
  • K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/ (November 17, 1997)
  • K973974 — DADE TRU-LIQUID CARDIAC CONTROL (November 6, 1997)
  • K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR (October 20, 1997)
  • K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (September 8, 1997)
  • K972782 — DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (August 15, 1997)
  • K964660 — PARAMAX CHOLESTEROL REAGENT (June 4, 1997)
  • K970676 — DRIED GRAM-NEGATIVE MIC/COMBO PANELS (May 2, 1997)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)
  • K970330 — DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE (April 14, 1997)

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