MR1 Follitropin Ria Kit
FDA 510(k) K820740 · Microanalytic Research, Inc.
510(k) numberK820740
Submission
- Device name
- MR1 Follitropin Ria Kit
- Applicant
- Microanalytic Research, Inc.
Mchenry, IL, US - Received
- March 18, 1982
- Decision date
- April 6, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
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| K002450 | Genua Menopause Monitor Test KitCGJ · Traditional | Genua 1944, Inc. | 01/12/2001SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | Monobind | 09/02/1997SE |
| K970085 | Sealite Sciences Aqualite FSHCGJ · Traditional | Sealite Sciences, Inc. | 02/14/1997SE |
| K964720 | Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)CGJ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/04/1997SE |
| K964693 | Elecsys FSH AssayCGJ · Traditional | Boehringer Mannheim Corp. | 12/16/1996SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861097 | Trypsin Ria KitJNO · Traditional | 05/29/1986SE |
| K820741 | MR1 Lutropin Ria KitCEP · Traditional | 04/14/1982SE |
| K813516 | MRI Tobramycin Ria KitKLB · Traditional | 12/29/1981SE |
| K812394 | MRI Gentamicin Ria KitDJB · Traditional | 09/08/1981SE |
| K810949 | MRI Prolactin Ria KitCFT · Traditional | 07/10/1981SE |
| K802754 | Immunoreactive Estriol Ria KitCGI · Traditional | 01/21/1981SE |
| K801491 | MRI Hcg-Beta Ria Kit Cat. #MR-10100JHI · Traditional | 08/13/1980SE |
Questions and answers
When was MR1 Follitropin Ria Kit cleared by the FDA?
MR1 Follitropin Ria Kit (K820740) received a 510(k) decision of Substantially Equivalent on April 6, 1982, 19 days after the submission was received.
What is the product code of K820740?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.