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510(k) K022533

FASTPACK TESTOSTERONE CALIBRATOR by Qualigen, Inc. — Product Code JIT

K022533 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FASTPACK TESTOSTERONE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on September 30, 2002. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Qualigen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2002
Date Received
July 31, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
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)
  • 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 JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)

FDA data resources