Aria II 125- I-Estriol System
FDA 510(k) K801735 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK801735
Submission
- Device name
- Aria II 125- I-Estriol System
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- July 25, 1980
- Decision date
- September 16, 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 |
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Questions and answers
When was Aria II 125- I-Estriol System cleared by the FDA?
Aria II 125- I-Estriol System (K801735) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 53 days after the submission was received.
What is the product code of K801735?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.