Lumatag T4 Chemiluminescence Assay
FDA 510(k) K911985 · London Diagnostics, Inc.
510(k) numberK911985
Submission
- Device name
- Lumatag T4 Chemiluminescence Assay
- Applicant
- London Diagnostics, Inc.
Eden Prairie, MN, US - Received
- May 6, 1991
- Decision date
- August 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDX – Radioimmunoassay, Total Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1700
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961490 | Elecsys T4 AssayCDX · Traditional | Boehringer Mannheim Corp. | 06/13/1996SE |
| K954312 | Active Thyroxine RiaCDX · Traditional | Diagnostic Systems Laboratories, Inc. | 10/07/1995SE |
| K943416 | Delfia Neonatal Thyroxine KitCDX · Traditional | Wallac OY | 03/10/1995SE |
| K934384 | Axsym(Tm) Total T4CDX · Traditional | Abbott Laboratories | 06/21/1994SE |
| K932980 | Total T4 Fpia Reagent Set/Calibrator #T-1039,T-116CDX · Traditional | Sigma Diagnostics, Inc. | 10/18/1993SE |
| K933426 | Stratus(R) Total THYROXINE(T4) Fluor Enzyme ImmunoCDX · Traditional | Baxter Diagnostics, Inc. | 08/26/1993SE |
| K931295 | Iq TT4 AssayCDX · Traditional | Becton Dickinson Advanced Diagnostics | 07/20/1993SE |
| K926563 | Autobead(Tm) T4 Enzyme Immunoassay Test KitCDX · Traditional | Bio-Chem Laboratory Systems, Inc. | 03/18/1993SE |
| K925110 | Abbott Imx T4CDX · Traditional | Abbott Laboratories | 01/26/1993SE |
| K925109 | Abbott Tdx/Tdxflx TT4CDX · Traditional | Abbott Laboratories | 01/04/1993SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K914835 | Lumatag Free T4 Chemiluminescence AssayCEC · Traditional | 12/17/1991SE |
| K912858 | London Diagnostics Lumatag(R) HGH Chem Immun AssayCFL · Traditional | 07/30/1991SE |
| K905814 | Lumatag(R) FSH Chemiluminescence Immunometri AssayCGJ · Traditional | 02/04/1991SE |
| K904458 | Lumatag(Tm) Prolactin Diagnostic Kit/ModificationCFT · Traditional | 10/12/1990SE |
| K903130 | London Diagnostics Lumatag(Tm) Intact PTH AssayCEW · Traditional | 09/25/1990SE |
| K903195 | London Diagnostics Lumatag (R) Ige Chem. Imm AssayDGC · Traditional | 08/02/1990SE |
| K902443 | Lumatag(Tm) LH Diagnostic KitCEP · Traditional | 08/02/1990SE |
| K901484 | Lumatag(Tm) HCG Chemiluminescence ImmunometricJHI · Traditional | 05/01/1990SE |
| K901075 | Lumatag(Tm) Ferritin Chemiluminescence Immunomet.DBF · Traditional | 04/02/1990SE |
| K881443 | Lumatag(Tm) TSH Chemiluminescence Immuno. AssayJLW · Traditional | 05/27/1988SE |
Questions and answers
When was Lumatag T4 Chemiluminescence Assay cleared by the FDA?
Lumatag T4 Chemiluminescence Assay (K911985) received a 510(k) decision of Substantially Equivalent on August 2, 1991, 88 days after the submission was received.
What is the product code of K911985?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.