Estriol Radioimmunoassay Test Kit
FDA 510(k) K810695 · Serono Laboratories, Inc.
510(k) numberK810695
Submission
- Device name
- Estriol Radioimmunoassay Test Kit
- Applicant
- Serono Laboratories, Inc.
Mchenry, IL, US - Received
- March 16, 1981
- Decision date
- March 31, 1981
- 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 |
|---|---|---|
| K834428 | Aldosterone Radioimmunoassay Test KitCJM · Traditional | 03/02/1984SE |
| K810625 | Human Placental Lactogen Radioimmuno-DHI · Traditional | 03/27/1981SE |
| K792043 | Pap-Check Ria KitJFH · Traditional | 10/30/1979SE |
| K790679 | Estradiol Ria KitCHP · Traditional | 05/23/1979SE |
| K790440 | ProgesteroneJLS · Traditional | 05/03/1979SE |
| K782143 | Ria Kit, GlucoseJME · Traditional | 02/22/1979SE |
| K782103 | Ria Kit, Neonatal T4CDX · Traditional | 01/17/1979SE |
| K781733 | Ria Kit, Preg-StatJHI · Traditional | 12/20/1978SE |
| K781285 | Insulin Ria KitCFP · Traditional | 08/14/1978SE |
Questions and answers
When was Estriol Radioimmunoassay Test Kit cleared by the FDA?
Estriol Radioimmunoassay Test Kit (K810695) received a 510(k) decision of Substantially Equivalent on March 31, 1981, 15 days after the submission was received.
What is the product code of K810695?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.