Fastpack Testosterone Calibrator
FDA 510(k) K022533 · Qualigen, Inc.
510(k) numberK022533
Submission
- Device name
- Fastpack Testosterone Calibrator
- Applicant
- Qualigen, Inc.
Carlsbad, CA, US - Received
- July 31, 2002
- Decision date
- September 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
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| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | 01/07/2015SE |
| K123983 | Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersMRG · Traditional | 07/03/2013SE |
| K123725 | Fastpack Control KitJJY · Traditional | 03/08/2013SE |
| K101388 | Fastpack Testo ImmunoassayCDZ · Special | 02/18/2011SE |
| K101390 | Fastpack TSH ImmunoassayJLW · Special | 08/13/2010SE |
| K072264 | Fastpack HCG ImmunoassayJHI · Traditional | 12/06/2007SE |
| K062957 | Fastpack Total Psa Method Verification KitJJX · Abbreviated | 04/02/2007SE |
| K052301 | Fastpack TSH ImmunoassayJLW · Traditional | 01/04/2006SE |
| K030329 | Fastpack Free T4 ImmunoassayCEC · Traditional | 07/03/2003SE |
Questions and answers
When was Fastpack Testosterone Calibrator cleared by the FDA?
Fastpack Testosterone Calibrator (K022533) received a 510(k) decision of Substantially Equivalent on September 30, 2002, 61 days after the submission was received.
What is the product code of K022533?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.