ARCHITECT 2nd Generation Testosterone
FDA 510(k) K152155 · Abbott Laboratories
510(k) numberK152155
Submission
- Device name
- ARCHITECT 2nd Generation Testosterone
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 3, 2015
- Decision date
- December 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K190121 | Ids SHBGCDZ · Traditional | Immunodiagnostic Systems , Ltd. | 06/17/2019SE |
| K182521 | FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional | Qualigen, Inc. | 01/29/2019SE |
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Questions and answers
When was ARCHITECT 2nd Generation Testosterone cleared by the FDA?
ARCHITECT 2nd Generation Testosterone (K152155) received a 510(k) decision of Substantially Equivalent on December 17, 2015, 136 days after the submission was received.
What is the product code of K152155?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.