Rianen Luteinizing Hormone Ria Kit
FDA 510(k) K833376 · New England Nuclear
510(k) numberK833376
Submission
- Device name
- Rianen Luteinizing Hormone Ria Kit
- Applicant
- New England Nuclear
Mchenry, IL, US - Received
- September 28, 1983
- Decision date
- December 20, 1983
- 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 |
|---|---|---|
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | 06/14/1984SE |
| K840301 | Rianen Estriol Radioimmunoassay KitCGI · Traditional | 03/30/1984SE |
| K834038 | Rianen Follicle Stimulating HormoneCGJ · Traditional | 01/30/1984SE |
| K831345 | Rianen Prolactin 125I KitCFT · Traditional | 06/08/1983SE |
| K801245 | Atomlight (Liquid Scintillation SolutionJJJ · Traditional | 06/20/1980SE |
| K792175 | Rianen, Vitamin B12 Assay SystemCDD · Traditional | 11/13/1979SE |
| K790817 | Ria Kit, Quantitation of Prostatic AcidJFH · Traditional | 05/07/1979SE |
| K782110 | Ria Kit, Rianen CortisolCGR · Traditional | 01/26/1979SE |
| K781888 | Assay System, Ferritin I KitJMG · Traditional | 01/10/1979SE |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | 09/14/1978SE |
Questions and answers
When was Rianen Luteinizing Hormone Ria Kit cleared by the FDA?
Rianen Luteinizing Hormone Ria Kit (K833376) received a 510(k) decision of Substantially Equivalent on December 20, 1983, 83 days after the submission was received.
What is the product code of K833376?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.