17B Estradiol
FDA 510(k) K810204 · Pantex, Div. Bio-Analysis, Inc.
510(k) numberK810204
Submission
- Device name
- 17B Estradiol
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
Mchenry, IL, US - Received
- January 26, 1981
- Decision date
- March 27, 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 |
|---|---|---|
| K102841 | Pantex Am/Pm Salivary Cortisol Enzyme ImmunoassayNHG · Traditional | 05/08/2012SE |
| K942658 | Neoscreen Elisa TSHJLW · Traditional | 02/24/1995SE |
| K914107 | Prolactin Irma ImmunomagCFT · Traditional | 09/30/1991SE |
| K912804 | FSH Irma ImmunomagCGJ · Traditional | 08/12/1991SE |
| K911839 | Neonatal Blood Spot Test 17-HYDROXPROG Radio KitJLX · Traditional | 06/18/1991SE |
| K911050 | LH Irma ImmunomagCEP · Traditional | 04/12/1991SE |
| K910717 | Pantex Irma LH 1251 KitCEP · Traditional | 03/19/1991SE |
| K894049 | Immunocoat Progesterone Radioimmunoassay KitJLS · Traditional | 09/08/1989SE |
| K862483 | Pantex Fte Free Testosterone Radioimmunoassay KitCDZ · Traditional | 01/14/1987SE |
| K862447 | Pancoat T3 Uptake Coated Tube Radioimmunoassay KitKHQ · Traditional | 10/07/1986SE |
Questions and answers
When was 17B Estradiol cleared by the FDA?
17B Estradiol (K810204) received a 510(k) decision of Substantially Equivalent on March 27, 1981, 60 days after the submission was received.
What is the product code of K810204?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.