Rianen Estriol Radioimmunoassay Kit
FDA 510(k) K840301 · New England Nuclear
510(k) numberK840301
Submission
- Device name
- Rianen Estriol Radioimmunoassay Kit
- Applicant
- New England Nuclear
Mchenry, IL, US - Received
- January 24, 1984
- Decision date
- March 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGI – Radioimmunoassay, Estriol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1265
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974721 | Unconjugated Estriol Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)CGI · Traditional | Bayer Corp. | 03/03/1998SE |
| K962875 | Active Ultrasensitive Unconjugated Estriol EiaCGI · Traditional | Diagnostic Systems Laboratories, Inc. | 08/23/1996SE |
| K955356 | Active Ultra-Sensitive Unconjugated EstriolCGI · Traditional | Diagnostic Systems Laboratories, Inc. | 05/15/1996SE |
| K932989 | Coat-A-Count Free EstriolCGI · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K944490 | Autodelfia Unconjugated Estriol (UE3) KitCGI · Traditional | Wallac OY | 12/09/1994SE |
| K920576 | Amerlex-M High Sensitivity Unconjugated EstriolCGI · Traditional | Eastman Kodak Company | 03/23/1992SE |
| K903359 | Microzyme Unconjugated Estriol Enzyme Immuno KitCGI · Traditional | Immunotech Corp. | 08/22/1990SE |
| K860900 | Immpulse Free Estriol Assay ReagentsCGI · Traditional | Sclavo, Inc. | 04/28/1986SE |
| K850787 | Solid Phase Free Estriol Enzyme ImmunoassayCGI · Traditional | Nms Pharmaceuticals, Inc. | 03/26/1985SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | Biotecx Laboratories, Inc. | 02/01/1985SE |
More from Biotecx Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | 06/14/1984SE |
| K834038 | Rianen Follicle Stimulating HormoneCGJ · Traditional | 01/30/1984SE |
| K833376 | Rianen Luteinizing Hormone Ria KitCEP · Traditional | 12/20/1983SE |
| K831345 | Rianen Prolactin 125I KitCFT · Traditional | 06/08/1983SE |
| K801245 | Atomlight (Liquid Scintillation SolutionJJJ · Traditional | 06/20/1980SE |
| K792175 | Rianen, Vitamin B12 Assay SystemCDD · Traditional | 11/13/1979SE |
| K790817 | Ria Kit, Quantitation of Prostatic AcidJFH · Traditional | 05/07/1979SE |
| K782110 | Ria Kit, Rianen CortisolCGR · Traditional | 01/26/1979SE |
| K781888 | Assay System, Ferritin I KitJMG · Traditional | 01/10/1979SE |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | 09/14/1978SE |
Questions and answers
When was Rianen Estriol Radioimmunoassay Kit cleared by the FDA?
Rianen Estriol Radioimmunoassay Kit (K840301) received a 510(k) decision of Substantially Equivalent on March 30, 1984, 66 days after the submission was received.
What is the product code of K840301?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.