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510(k) K123725

FASTPACK CONTROL KIT by Qualigen, Inc. — Product Code JJY

K123725 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FASTPACK CONTROL KIT". The FDA issued a decision of Substantially Equivalent on March 8, 2013. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), 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
March 8, 2013
Date Received
December 4, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
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)
  • 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)
  • K022533 — FASTPACK TESTOSTERONE CALIBRATOR (September 30, 2002)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources