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510(k) K981634

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS by Biocircuits Corp. — Product Code LTJ

K981634 is an FDA 510(k) premarket notification submitted by Biocircuits Corp. for the device "BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS". The FDA issued a decision of Substantially Equivalent on October 13, 1998. 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. Biocircuits Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1998
Date Received
May 8, 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

Other clearances by Biocircuits Corp.

  • K980819 — BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS (April 3, 1998)
  • K963770 — BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CON (December 5, 1996)
  • K961566 — BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS (November 18, 1996)
  • K961792 — BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS (August 21, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K953837 — BIOCIRCUITS IOS T4 TEST CARTRIDGE (November 20, 1995)
  • K952751 — BIOCIRCUITS IOS T4/TU TEST CARTRIDGES (November 20, 1995)

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