Fastpack Control Kit
FDA 510(k) K123725 · Qualigen, Inc.
510(k) numberK123725
Submission
- Device name
- Fastpack Control Kit
- Applicant
- Qualigen, Inc.
Carlsbad, CA, US - Received
- December 4, 2012
- Decision date
- March 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Decision |
|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional | 01/29/2019SE |
| 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 |
| 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 |
| K022533 | Fastpack Testosterone CalibratorJIT · Abbreviated | 09/30/2002SE |
Questions and answers
When was Fastpack Control Kit cleared by the FDA?
Fastpack Control Kit (K123725) received a 510(k) decision of Substantially Equivalent on March 8, 2013, 94 days after the submission was received.
What is the product code of K123725?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.