MR1 Lutropin Ria Kit
FDA 510(k) K820741 · Microanalytic Research, Inc.
510(k) numberK820741
Submission
- Device name
- MR1 Lutropin Ria Kit
- Applicant
- Microanalytic Research, Inc.
Mchenry, IL, US - Received
- March 18, 1982
- Decision date
- April 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013582 | Maybe?Mom Mini Ovulation MicroscopeCEP · Traditional | Maybe?Mom | 01/16/2003SE |
| K022829 | Instant-View LH Ovulation Predicting TestCEP · Abbreviated | Alfa Scientific Designs, Inc. | 11/05/2002SE |
| K021409 | At Home Ovulation Test, Model 9032CEP · Special | Phamatech, Inc. | 05/24/2002SE |
| K013874 | Clearplane Easy Ovulation TestCEP · Traditional | Unipath , Ltd. | 02/19/2002SE |
| K013323 | TCI-31 Lifelong Ovulation TesterCEP · Traditional | Tci New York | 12/05/2001SE |
| K012252 | Quik-Check Ovulation PredictorCEP · Traditional | ACON Laboratories, Inc. | 08/24/2001SE |
| K010244 | Sure Check Ovulation PredictorCEP · Traditional | Chembio Diagnostic Systems, Inc. | 05/02/2001SE |
| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | Selfcare, Inc. | 10/12/2000SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
More from Selfcare, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861097 | Trypsin Ria KitJNO · Traditional | 05/29/1986SE |
| K820740 | MR1 Follitropin Ria KitCGJ · Traditional | 04/06/1982SE |
| 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 Lutropin Ria Kit cleared by the FDA?
MR1 Lutropin Ria Kit (K820741) received a 510(k) decision of Substantially Equivalent on April 14, 1982, 27 days after the submission was received.
What is the product code of K820741?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.