Access Total T3 Reagents on the Access Immunoassay Analyzer
FDA 510(k) K973966 · Beckman Instruments, Inc.
510(k) numberK973966
Submission
- Device name
- Access Total T3 Reagents on the Access Immunoassay Analyzer
- Applicant
- Beckman Instruments, Inc.
Chaska, MN, US - Received
- October 17, 1997
- Decision date
- October 31, 1997
- 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
Other 510(k)s with product code CDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001607 | Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104)CDP · Traditional | Repromedix Corp. | 10/05/2000SE |
| 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 |
| K971779 | Total TRIIODOTHYRONINE(T3) Microplate EiaCDP · Traditional | Monobind | 06/16/1997SE |
More from Monobind
| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Access Total T3 Reagents on the Access Immunoassay Analyzer cleared by the FDA?
Access Total T3 Reagents on the Access Immunoassay Analyzer (K973966) received a 510(k) decision of Substantially Equivalent on October 31, 1997, 14 days after the submission was received.
What is the product code of K973966?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.