Clinical Assays Gamma Coat Free T4 Radioimm. Kit
FDA 510(k) K915235 · Incstar Corp.
510(k) numberK915235
Submission
- Device name
- Clinical Assays Gamma Coat Free T4 Radioimm. Kit
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- November 22, 1991
- Decision date
- January 28, 1992
- 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 |
|---|---|---|
| K963289 | Incstar Toxoplasma Igm Capture Elisa AssayLGD · Traditional | 05/01/1997SE |
| K963297 | Incstar Toxoplasma Igg Fast Elisa Assay (CAT.#7560)LGD · Traditional | 12/16/1996SE |
| K963296 | Incstar Toxoplasma Igg Alisa Assay (CAT.#7565)LGD · Traditional | 12/16/1996SE |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530LFZ · Traditional | 10/17/1996SE |
| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955362 | Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was Clinical Assays Gamma Coat Free T4 Radioimm. Kit cleared by the FDA?
Clinical Assays Gamma Coat Free T4 Radioimm. Kit (K915235) received a 510(k) decision of Substantially Equivalent on January 28, 1992, 67 days after the submission was received.
What is the product code of K915235?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.