T-3 Microwell Eia Model 7013
FDA 510(k) K960412 · Biomerica, Inc.
510(k) numberK960412
Submission
- Device name
- T-3 Microwell Eia Model 7013
- Applicant
- Biomerica, Inc.
Newport Beach, CA, US - Received
- January 29, 1996
- Decision date
- March 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDP – Radioimmunoassay, Total Triiodothyronine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1710
- Specialty
- Clinical Chemistry
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| K991692 | Chiron Diagnostics Acs: 180 FT3CDP · Traditional | Chiron Diagnostics Corp. | 06/18/1999SE |
| K991311 | Total T3 Enzyme Immunoassay Test Kit, Model BC-1005CDP · Traditional | Biocheck, Inc. | 06/02/1999SE |
| K991252 | Aia-Pack FT3 AssayCDP · Traditional | Tosoh Medics, Inc. | 05/11/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | Biotecx Laboratories, Inc. | 12/22/1998SE |
| K983439 | Abbott Architect Free T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K983434 | Abbott Architect Total T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K974027 | Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator PackCDP · Traditional | Alfa Biotech (Uk) , Ltd. | 02/02/1998SE |
| K974634 | Immulite Free T3CDP · Traditional | Diagnostic Products Corp. | 01/02/1998SE |
| K973966 | Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
More from Beckman Instruments, Inc.
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| K003856 | Ez-Hcg Urine(Pregnancy Test)JHI · Traditional | 02/21/2001SE |
| K982954 | Free T4 Microwell Eia, Model #7019CEC · Traditional | 09/24/1998SE |
| K962216 | TSH (Microwell) ElisaJLW · Traditional | 09/19/1996SE |
| K954256 | Anti-TpoJNL · Traditional | 11/27/1995SE |
| K950588 | T4 Microwell Eia (Enzyme IMMUNOASSAY0KLI · Traditional | 06/29/1995SE |
| K936010 | Thyroglobulin Autoantibody Enzyme ImmunoassayDDC · Traditional | 07/18/1994SE |
| K915185 | Gap Igg H.Pylori ModifiedLYR · Traditional | 03/04/1992SE |
| K900343 | Gap-IggLYR · Traditional | 08/22/1991SE |
Questions and answers
When was T-3 Microwell Eia Model 7013 cleared by the FDA?
T-3 Microwell Eia Model 7013 (K960412) received a 510(k) decision of Substantially Equivalent on March 19, 1996, 50 days after the submission was received.
What is the product code of K960412?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.