# Qualigen, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 15 (2000–2019): 15 510(k) clearances
- Product codes: CDZ (3), JIT (2), JJX (2), JLW (2), DCK (1), LTJ (1), CEC (1), JJY (1), MRG (1), JHI (1)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)
- Medical Analysis Systems, Inc.: 1 (https://510kreport.com/company/medical-analysis-systems)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Firms that cite its devices most
- Magnabiosciences, LLC: 1 (https://510kreport.com/company/magnabiosciences)

## Its most-cited devices
- K052301: Fastpack TSH Immunoassay (2006), cited by 2
- K003095: Fastpack Control (2000), cited by 1
- K021972: Fastpack Total Testosterone Immunoassay (2002), cited by 1

## Recent decisions
- K182521: FastPack IP Sex Hormone Binding Globulin Immunoassay (Jan 29, 2019)
- K141689: FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (Jan 7, 2015)
- K123983: Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers (Jul 3, 2013)
- K123725: Fastpack Control Kit (Mar 8, 2013)
- K101388: Fastpack Testo Immunoassay (Feb 18, 2011)
- K101390: Fastpack TSH Immunoassay (Aug 13, 2010)
- K072264: Fastpack HCG Immunoassay (Dec 6, 2007)
- K062957: Fastpack Total Psa Method Verification Kit (Apr 2, 2007)

Source page: https://510kreport.com/company/qualigen