Ria Kit, Gammadab Estriol
FDA 510(k) K781938 · Clinical Assays, Inc.
510(k) numberK781938
Submission
- Device name
- Ria Kit, Gammadab Estriol
- Applicant
- Clinical Assays, Inc.
Mchenry, IL, US - Received
- November 20, 1978
- Decision date
- January 10, 1979
- 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 |
|---|---|---|
| K832712 | Folate Radioassay Kit CA-1562-125CGN · Traditional | 10/04/1983SE |
| K832711 | Vitamin B12 Folate CA-1515-125CDD · Traditional | 10/04/1983SE |
| K832710 | Vitamin B12 Radioassay Kit CA-1534CDD · Traditional | 10/04/1983SE |
| K823476 | Gammadab LH Radio-Kit #CA-1508CEP · Traditional | 12/28/1982SE |
| K823313 | In Vitro Gammacoat B-Hcg Radio. TestJHI · Traditional | 12/22/1982SE |
| K821611 | Gammadab [125] FSH Radioimmunay KitCGJ · Traditional | 06/24/1982SE |
| K821092 | GAMMADAB[125]EGE Radioimmunoassay ItDGC · Traditional | 06/22/1982SE |
| K812227 | Gammacoat (125) Insulin RadioimmunoassayCFP · Traditional | 09/24/1981SE |
| K810722 | Gastrin Radioimmunoassay TestCGC · Traditional | 05/27/1981SE |
| K810967 | In-Vitro TBG Radioimmunoassay TestCEE · Traditional | 04/23/1981SE |
Questions and answers
When was Ria Kit, Gammadab Estriol cleared by the FDA?
Ria Kit, Gammadab Estriol (K781938) received a 510(k) decision of Substantially Equivalent on January 10, 1979, 51 days after the submission was received.
What is the product code of K781938?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.