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510(k) K984289

VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK by Ortho-Clinical Diagnostics, Inc. — Product Code LTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1999
Date Received
December 1, 1998
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

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Other clearances for product code LTJ

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  • 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)