Home / 510(k) Clearances / K062957

510(k) K062957

FASTPACK TOTAL PSA METHOD VERIFICATION KIT by Qualigen, Inc. — Product Code JJX

K062957 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FASTPACK TOTAL PSA METHOD VERIFICATION KIT". The FDA issued a decision of Substantially Equivalent on April 2, 2007. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Qualigen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2007
Date Received
September 29, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
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)
  • K052301 — FASTPACK TSH IMMUNOASSAY (January 4, 2006)
  • K030329 — FASTPACK FREE T4 IMMUNOASSAY (July 3, 2003)
  • K022533 — FASTPACK TESTOSTERONE CALIBRATOR (September 30, 2002)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources