Terumo Sensibead(Tm) Eia Estradiol Kit
FDA 510(k) K882343 · Terumo Medical Corp.
510(k) numberK882343
Submission
- Device name
- Terumo Sensibead(Tm) Eia Estradiol Kit
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- June 7, 1988
- Decision date
- July 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHP – Radioimmunoassay, Estradiol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041349 | Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and SerumCHP · Traditional | Ibl GmbH | 09/24/2004SE |
| K973901 | 17 B-Estradiol (Elisa)CHP · Traditional | Kmi Diagnostics, Inc. | 11/24/1997SE |
| K973743 | Access Estradiol Reagents on the Access Immunoassay AnalyzerCHP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
| K970386 | Acs ESTADIOL-6 IICHP · Traditional | Chiron Diagnostics Corp. | 06/04/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 03/18/1997SE |
| K970126 | Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)CHP · Traditional | Bio-Rad Laboratories, Inc. | 02/25/1997SE |
| K965109 | Elecsys Estradiol AssayCHP · Traditional | Boehringer Mannheim Corp. | 02/18/1997SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | Biomerieux Vitek, Inc. | 02/06/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | Ciba Corning Diagnostics Corp. | 12/13/1995SE |
| K953605 | Ultra-Sensitive EstradiolCHP · Traditional | Diagnostic Systems Laboratories, Inc. | 10/02/1995SE |
More from Diagnostic Systems Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231044 | R2P NavicrossDQY · Traditional | 07/27/2023SE |
| K213531 | TR BAND Radial Compression DeviceDXC · Traditional | 12/20/2021SE |
| K193125 | R2P Destination Slender Guiding SheathDYB · Traditional | 01/06/2020SE |
| K181237 | Glidesheath Slender Tibial Pedal KitDYB · Traditional | 08/03/2018SE |
| K173831 | Glidesheath SlenderDYB · Traditional | 05/08/2018SE |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…DYB · Traditional | 11/21/2017SE |
| K171491 | R2P Destination Slender Guiding SheathDYB · Traditional | 10/05/2017SE |
| K152173 | GlidesheathDYB · Traditional | 12/01/2015SE |
| K152525 | TR BAND Radial Compression DeviceDXC · Traditional | 11/10/2015SE |
| K151471 | Radifocus Glidewire Endoscopic WireOCY · Traditional | 09/17/2015SE |
Questions and answers
When was Terumo Sensibead(Tm) Eia Estradiol Kit cleared by the FDA?
Terumo Sensibead(Tm) Eia Estradiol Kit (K882343) received a 510(k) decision of Substantially Equivalent on July 1, 1988, 24 days after the submission was received.
What is the product code of K882343?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.