Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum
FDA 510(k) K041349 · Ibl GmbH
510(k) numberK041349
Submission
- Device name
- Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum
- Applicant
- Ibl GmbH
East Stroudsburg, PA, US - Received
- May 20, 2004
- Decision date
- September 24, 2004
- 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K051969 | Tricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin)…CHQ · Traditional | 10/03/2005SE |
| K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional | 07/22/2004SE |
| K033786 | Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and SalivaJIT · Traditional | 02/27/2004SE |
| K032796 | Ibl C3D-CIC Eia TestCZW · Traditional | 01/13/2004SE |
| K032254 | Ibl C1Q-CIC Cia TestDAK · Traditional | 08/29/2003SE |
Questions and answers
When was Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum cleared by the FDA?
Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum (K041349) received a 510(k) decision of Substantially Equivalent on September 24, 2004, 127 days after the submission was received.
What is the product code of K041349?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.