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510(k) K003094

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER by Qualigen, Inc. — Product Code LTJ

K003094 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER". The FDA issued a decision of Substantially Equivalent on October 25, 2000. 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. Qualigen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2000
Date Received
October 3, 2000
Clearance Type
Special
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 Qualigen, Inc.

  • K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay (January 29, 2019)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K123983 — FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS (July 3, 2013)
  • K123725 — FASTPACK CONTROL KIT (March 8, 2013)
  • K101388 — FASTPACK TESTO IMMUNOASSAY (February 18, 2011)
  • K101390 — FASTPACK TSH IMMUNOASSAY (August 13, 2010)
  • K072264 — FASTPACK HCG IMMUNOASSAY (December 6, 2007)
  • K062957 — FASTPACK TOTAL PSA METHOD VERIFICATION KIT (April 2, 2007)
  • K052301 — FASTPACK TSH IMMUNOASSAY (January 4, 2006)
  • K030329 — FASTPACK FREE T4 IMMUNOASSAY (July 3, 2003)

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)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (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)
  • K002121 — TOTAL PSA MICROTITER ELISA (August 30, 2000)

FDA data resources