Acs ESTADIOL-6 II
FDA 510(k) K970386 · Chiron Diagnostics Corp.
510(k) numberK970386
Submission
- Device name
- Acs ESTADIOL-6 II
- Applicant
- Chiron Diagnostics Corp.
Medfield, MA, US - Received
- February 3, 1997
- Decision date
- June 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K951360 | Estradiol Assay for the Technicon Immuno 1 System In-Vitro Diagnostic SystemCHP · Traditional | Bayer Corp. | 05/02/1995SE |
More from Bayer Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K992157 | Chiron Diagnostics Acs: 180 Ferritin AssayDBF · Traditional | 08/05/1999SE |
| K991582 | Chiron Diagnostics Acs: 180 FolateCGN · Traditional | 06/30/1999SE |
| K991692 | Chiron Diagnostics Acs: 180 FT3CDP · Traditional | 06/18/1999SE |
| K982680 | Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayMOI · Traditional | 10/15/1998SE |
| K981839 | Acs:Centaur PSA2 ImmunoassayLTJ · Traditional | 08/12/1998SE |
| K981478 | Acs:Centaur CeaDHX · Traditional | 08/12/1998SE |
| K981592 | Acs:Centaur AfpLOQ · Traditional | 07/07/1998SE |
| K980528 | Chiron Diagnostics ACS:180 Troponin I Assay (Ctni)MMI · Traditional | 03/03/1998SE |
| K974029 | Acs TobramycinLCR · Traditional | 02/12/1998SE |
| K974325 | Chiron Diagnostics ACS:180 MyoglobinDDR · Traditional | 12/08/1997SE |
Questions and answers
When was Acs ESTADIOL-6 II cleared by the FDA?
Acs ESTADIOL-6 II (K970386) received a 510(k) decision of Substantially Equivalent on June 4, 1997, 121 days after the submission was received.
What is the product code of K970386?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.