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510(k) K964595

OPUS PSA TEST SYSTEM by Behring Diagnostics, Inc. — Product Code LTJ

K964595 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "OPUS PSA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 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. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1997
Date Received
November 18, 1996
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 Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K971725 — OPUS PROGESTERONE (June 18, 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