Biocheck Testosterone Eia, Model BC-1115
FDA 510(k) K002294 · Biocheck, Inc.
510(k) numberK002294
Submission
- Device name
- Biocheck Testosterone Eia, Model BC-1115
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- July 27, 2000
- Decision date
- October 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|
| K041619 | Bio Check Whole Blood/Plasma/Sermon Model #801116MMI · Traditional | 12/17/2004SE |
| K040030 | Biocheck CARDIAC-1 CRP Rapid Test, Model BC-804114DCN · Traditional | 06/16/2004SE |
| K022660 | Biocheck Myoglobin Elisa, Model BC-1117DRR · Traditional | 12/19/2002SE |
| K013062 | Biocheck Human Cardiac Troponin-I Immunoassay Test KitMMI · Traditional | 01/08/2002SE |
| K003851 | Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119DCK · Traditional | 07/20/2001SE |
| K001022 | Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model BC-1061JZG · Traditional | 09/26/2000SE |
| K992517 | Biocheck Ferritin Elisa Model BC-1025DBF · Traditional | 09/24/1999SE |
| K992528 | Biocheck Ige Elisa, Model BC-1035DGC · Traditional | 09/21/1999SE |
| K991741 | Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027JHI · Traditional | 07/22/1999SE |
| K991146 | TSH Enzyme Immunoassay Test Kit, Model #BC-1001JLW · Traditional | 06/22/1999SE |
Questions and answers
When was Biocheck Testosterone Eia, Model BC-1115 cleared by the FDA?
Biocheck Testosterone Eia, Model BC-1115 (K002294) received a 510(k) decision of Substantially Equivalent on October 2, 2000, 67 days after the submission was received.
What is the product code of K002294?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.