Estriol-Squibb Ria Kit
FDA 510(k) K802455 · E. R. Squibb & Sons, Inc.
510(k) numberK802455
Submission
- Device name
- Estriol-Squibb Ria Kit
- Applicant
- E. R. Squibb & Sons, Inc.
New York, NY, US - Received
- October 8, 1980
- Decision date
- October 31, 1980
- 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 |
|---|---|---|
| K821494 | Ria Stat 16JJJ · Traditional | 06/03/1982SE |
| K820616 | Angiotensis I-Squibb RadioimmunoassayCIB · Traditional | 03/26/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | 03/04/1982SE |
| K820340 | T3 Uptake-Squibb Diagnostic KitKHQ · Traditional | 03/04/1982SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | 06/16/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | 06/09/1981SE |
| K811160 | Sur-Fit Irrigation SleeveEXD · Traditional | 06/02/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | 04/21/1981SE |
| K810211 | T3 Ria KitCDP · Traditional | 02/10/1981SE |
Questions and answers
When was Estriol-Squibb Ria Kit cleared by the FDA?
Estriol-Squibb Ria Kit (K802455) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 23 days after the submission was received.
What is the product code of K802455?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.