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510(k) K973101

PROSTATE SPECIFIC ANTIGEN METHOD by Dade Chemistry Systems, Inc. — Product Code LTJ

K973101 is an FDA 510(k) premarket notification submitted by Dade Chemistry Systems, Inc. for the device "PROSTATE SPECIFIC ANTIGEN METHOD". The FDA issued a decision of Substantially Equivalent on September 18, 1997. The device falls under product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers), a Class II device regulated under 21 CFR 866.6010. Dade Chemistry Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1997
Date Received
August 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
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)
  • K973099 — PROSTATE SPECIFIC ANTIGEN CONTROL (September 29, 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 LTJ

  • K251630 — Atellica IM Total PSA II (tPSAII) (January 5, 2026)
  • K162378 — FREND PSA PLUS (reagent cartridge) (May 17, 2017)
  • K124056 — FREND PSA PLUS (REAGENT CARTRIDGE) (May 29, 2013)
  • K031343 — TPSA FLEX REAGENT CARTRIDGE (May 15, 2003)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K010550 — VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (April 24, 2001)
  • K003963 — DIMENSION PSA FLEX REAGENT CARTRIDGE (February 28, 2001)
  • K002376 — ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (October 26, 2000)
  • K003094 — FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (October 25, 2000)

FDA data resources