Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)
FDA 510(k) K970126 · Bio-Rad Laboratories, Inc.
510(k) numberK970126
Submission
- Device name
- Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- January 14, 1997
- Decision date
- February 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| 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 |
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Questions and answers
When was Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545) cleared by the FDA?
Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545) (K970126) received a 510(k) decision of Substantially Equivalent on February 25, 1997, 42 days after the submission was received.
What is the product code of K970126?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.