T3 Clasp-Bead Eia Kit
FDA 510(k) K893620 · Biotecx Laboratories, Inc.
510(k) numberK893620
Submission
- Device name
- T3 Clasp-Bead Eia Kit
- Applicant
- Biotecx Laboratories, Inc.
Friendswood, TX, US - Received
- May 11, 1989
- Decision date
- August 11, 1989
- 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 |
|---|---|---|
| K982298 | Opticoat T4 Eia KitKLI · Traditional | 02/03/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | 12/22/1998SE |
| K895407 | Cortisol Clasp-Bead Eia KitCGR · Traditional | 10/19/1989SE |
| K892853 | T4 Clasp-Bead Eia KitKLI · Traditional | 05/22/1989SE |
| K883765 | TBG 125I Ria Kit, Radioimmuno. of Serum ThyroxineKHQ · Traditional | 10/31/1988SE |
| K871211 | Progesterone Clasp Radioimmunoassay KitJLS · Traditional | 04/13/1987SE |
| K863188 | HPL Ria KitJMX · Traditional | 09/25/1986SE |
| K854876 | Aldosterone Direct Ria KitKQN · Traditional | 03/17/1986SE |
| K851540 | Estradiol Direct Ria KitCHP · Traditional | 06/06/1985SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | 02/01/1985SE |
Questions and answers
When was T3 Clasp-Bead Eia Kit cleared by the FDA?
T3 Clasp-Bead Eia Kit (K893620) received a 510(k) decision of Substantially Equivalent on August 11, 1989, 92 days after the submission was received.
What is the product code of K893620?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.