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510(k) K973099

PROSTATE SPECIFIC ANTIGEN CONTROL by Dade Chemistry Systems, Inc. — Product Code JJX

K973099 is an FDA 510(k) premarket notification submitted by Dade Chemistry Systems, Inc. for the device "PROSTATE SPECIFIC ANTIGEN CONTROL". The FDA issued a decision of Substantially Equivalent on September 29, 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 Chemistry Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
August 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 Chemistry Systems, Inc.

  • K973650 — TROPONIN (TROP) METHOD (October 20, 1997)
  • K973100 — PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR (September 29, 1997)
  • K973101 — PROSTATE SPECIFIC ANTIGEN METHOD (September 18, 1997)
  • K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (April 28, 1997)
  • K970387 — HUMAN CHORIONIC GONADOTROPIN METHOD (March 10, 1997)
  • K970393 — THYROID STIMULATING HORMONE METHOD (March 3, 1997)
  • K970336 — MMB CALIBRATOR (March 3, 1997)
  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K970389 — THYROID CALIBRATOR (February 18, 1997)
  • K970343 — MMB METHOD (February 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