Sri T3 Immoenzymetric Assay
FDA 510(k) K910737 · Serono-Baker Diagnostics, Inc.
510(k) numberK910737
Submission
- Device name
- Sri T3 Immoenzymetric Assay
- Applicant
- Serono-Baker Diagnostics, Inc.
Allentown, PA, US - Received
- February 21, 1991
- Decision date
- May 1, 1991
- 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 |
|---|---|---|
| K924257 | Testosterone Serozyme(Tm) Enzyme ImmunoassayCDZ · Traditional | 11/30/1992SE |
| K915164 | Sri Testosterone Enzyme ImmunoassayCDZ · Traditional | 03/02/1992SE |
| K914886 | Sri(Tm) Cortisol Enzyme Immunoassay(Mag Sol Phase)CGR · Traditional | 03/02/1992SE |
| K915602 | Sri Digoxin Enzyme ImmunoassayKXT · Traditional | 01/17/1992SE |
| K912937 | SR1 Free T4 Enzyme ImmunoassayCEC · Traditional | 11/19/1991SE |
| K914462 | Sri Progesterone Enzyme Immunoassay(Mag Sold Phas)JLS · Traditional | 10/23/1991SE |
| K911912 | SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)KHQ · Traditional | 09/18/1991SE |
| K911217 | SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)KLI · Traditional | 08/16/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | 07/25/1991SE |
| K911396 | SR1 Estradiol Enzyme ImmunoassayCHP · Traditional | 05/28/1991SE |
Questions and answers
When was Sri T3 Immoenzymetric Assay cleared by the FDA?
Sri T3 Immoenzymetric Assay (K910737) received a 510(k) decision of Substantially Equivalent on May 1, 1991, 69 days after the submission was received.
What is the product code of K910737?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.