Nordiclab Estradiol Ria Test
FDA 510(k) K800920 · Nordiclab Intl.
510(k) numberK800920
Submission
- Device name
- Nordiclab Estradiol Ria Test
- Applicant
- Nordiclab Intl.
Walker, MI, US - Received
- April 21, 1980
- Decision date
- May 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHP – Radioimmunoassay, Estradiol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041349 | Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and SerumCHP · Traditional | Ibl GmbH | 09/24/2004SE |
| K973901 | 17 B-Estradiol (Elisa)CHP · Traditional | Kmi Diagnostics, Inc. | 11/24/1997SE |
| K973743 | Access Estradiol Reagents on the Access Immunoassay AnalyzerCHP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
| K970386 | Acs ESTADIOL-6 IICHP · Traditional | Chiron Diagnostics Corp. | 06/04/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 03/18/1997SE |
| K970126 | Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)CHP · Traditional | Bio-Rad Laboratories, Inc. | 02/25/1997SE |
| K965109 | Elecsys Estradiol AssayCHP · Traditional | Boehringer Mannheim Corp. | 02/18/1997SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | Biomerieux Vitek, Inc. | 02/06/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | Ciba Corning Diagnostics Corp. | 12/13/1995SE |
| K953605 | Ultra-Sensitive EstradiolCHP · Traditional | Diagnostic Systems Laboratories, Inc. | 10/02/1995SE |
More from Diagnostic Systems 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 |
| K792189 | Nordiclab Total Estriol Ria TestCGI · Traditional | 11/13/1979SE |
| K782157 | Irma Test, Nordiclab FerritinJMG · Traditional | 01/17/1979SE |
| K782099 | Ria Test, Nordicalb HPLJMF · Traditional | 01/10/1979SE |
Questions and answers
When was Nordiclab Estradiol Ria Test cleared by the FDA?
Nordiclab Estradiol Ria Test (K800920) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 23 days after the submission was received.
What is the product code of K800920?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.