Fastpack Testo Immunoassay
FDA 510(k) K101388 · Qualigen, Inc.
510(k) numberK101388
Submission
- Device name
- Fastpack Testo Immunoassay
- Applicant
- Qualigen, Inc.
Carlsbad, CA, US - Received
- May 17, 2010
- Decision date
- February 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1680
- Specialty
- Clinical Chemistry
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| K182521 | FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional | Qualigen, Inc. | 01/29/2019SE |
More from Qualigen, Inc.
| 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 |
| K123725 | Fastpack Control KitJJY · Traditional | 03/08/2013SE |
| 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 Testo Immunoassay cleared by the FDA?
Fastpack Testo Immunoassay (K101388) received a 510(k) decision of Substantially Equivalent on February 18, 2011, 277 days after the submission was received.
What is the product code of K101388?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.