T4 Diagnostic Kit
FDA 510(k) K820251 · Diagnostic Reagents, Inc.
510(k) numberK820251
Submission
- Device name
- T4 Diagnostic Kit
- Applicant
- Diagnostic Reagents, Inc.
Walker, MI, US - Received
- January 29, 1982
- Decision date
- May 5, 1982
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
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| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
Questions and answers
When was T4 Diagnostic Kit cleared by the FDA?
T4 Diagnostic Kit (K820251) received a 510(k) decision of Substantially Equivalent on May 5, 1982, 96 days after the submission was received.
What is the product code of K820251?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.