Estradiol Direct Ria Kit
FDA 510(k) K851540 · Biotecx Laboratories, Inc.
510(k) numberK851540
Submission
- Device name
- Estradiol Direct Ria Kit
- Applicant
- Biotecx Laboratories, Inc.
Friendswood, TX, US - Received
- April 16, 1985
- Decision date
- June 6, 1985
- 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 |
|---|---|---|
| K982298 | Opticoat T4 Eia KitKLI · Traditional | 02/03/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | 12/22/1998SE |
| K895407 | Cortisol Clasp-Bead Eia KitCGR · Traditional | 10/19/1989SE |
| K893620 | T3 Clasp-Bead Eia KitCDP · Traditional | 08/11/1989SE |
| K892853 | T4 Clasp-Bead Eia KitKLI · Traditional | 05/22/1989SE |
| K883765 | TBG 125I Ria Kit, Radioimmuno. of Serum ThyroxineKHQ · Traditional | 10/31/1988SE |
| K871211 | Progesterone Clasp Radioimmunoassay KitJLS · Traditional | 04/13/1987SE |
| K863188 | HPL Ria KitJMX · Traditional | 09/25/1986SE |
| K854876 | Aldosterone Direct Ria KitKQN · Traditional | 03/17/1986SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | 02/01/1985SE |
Questions and answers
When was Estradiol Direct Ria Kit cleared by the FDA?
Estradiol Direct Ria Kit (K851540) received a 510(k) decision of Substantially Equivalent on June 6, 1985, 51 days after the submission was received.
What is the product code of K851540?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.