Nordiclab Total Estriol Ria Test
FDA 510(k) K792189 · Nordiclab Intl.
510(k) numberK792189
Submission
- Device name
- Nordiclab Total Estriol Ria Test
- Applicant
- Nordiclab Intl.
Mchenry, IL, US - Received
- October 31, 1979
- Decision date
- November 13, 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 |
|---|---|---|
| K801988 | Nordiclab Prostatic Acid Phosphatase RiaJFH · Traditional | 09/26/1980SE |
| K801989 | Nordiclab Ferritin Irma TestDBF · Traditional | 09/16/1980SE |
| K800922 | Nordiclab Progesterone Ria TestJLS · Traditional | 05/14/1980SE |
| K800921 | Nordiclab Testosterone Ria TestCDZ · Traditional | 05/14/1980SE |
| K800920 | Nordiclab Estradiol Ria TestCHP · Traditional | 05/14/1980SE |
| K782157 | Irma Test, Nordiclab FerritinJMG · Traditional | 01/17/1979SE |
| K782099 | Ria Test, Nordicalb HPLJMF · Traditional | 01/10/1979SE |
Questions and answers
When was Nordiclab Total Estriol Ria Test cleared by the FDA?
Nordiclab Total Estriol Ria Test (K792189) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 13 days after the submission was received.
What is the product code of K792189?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.