Tosoh Aia-Pack T3
FDA 510(k) K897001 · Tosoh Corp.
510(k) numberK897001
Submission
- Device name
- Tosoh Aia-Pack T3
- Applicant
- Tosoh Corp.
Washington, D.C., DC, US - Received
- December 18, 1989
- Decision date
- March 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K973966 | Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023240 | ST Aia-Pack Ca 19-9NIG · Traditional | 12/23/2002SE |
| K023239 | Aia-Pack Ca 19-9NIG · Traditional | 12/23/2002SE |
| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | 07/21/1992SE |
| K913663 | Aia-Pack T-UKHQ · Traditional | 09/30/1991SE |
| K913298 | Aia-Pack Ck-MbJHX · Traditional | 09/27/1991SE |
| K913493 | Aia-Pack FT4CEC · Traditional | 09/10/1991SE |
| K903628 | Aia-Pack IriCFP · Traditional | 09/07/1990SE |
| K901965 | MPR-4A - Micro-Plate ReaderJJQ · Traditional | 05/10/1990SE |
| K901674 | AIA-600 Automated Enzyme Immunoassay SystemKHO · Traditional | 05/02/1990SE |
| K896982 | Aia-Pack T4KLI · Traditional | 03/09/1990SE |
Questions and answers
When was Tosoh Aia-Pack T3 cleared by the FDA?
Tosoh Aia-Pack T3 (K897001) received a 510(k) decision of Substantially Equivalent on March 9, 1990, 81 days after the submission was received.
What is the product code of K897001?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.