Amerlex-M T3 Ria Kit for Serum and Plasma
FDA 510(k) K860252 · Amersham Corp.
510(k) numberK860252
Submission
- Device name
- Amerlex-M T3 Ria Kit for Serum and Plasma
- Applicant
- Amersham Corp.
Arlington Heights, IL, US - Received
- January 24, 1986
- Decision date
- February 11, 1986
- 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 |
|---|---|---|
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | 02/18/1992SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
Questions and answers
When was Amerlex-M T3 Ria Kit for Serum and Plasma cleared by the FDA?
Amerlex-M T3 Ria Kit for Serum and Plasma (K860252) received a 510(k) decision of Substantially Equivalent on February 11, 1986, 18 days after the submission was received.
What is the product code of K860252?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.