Bioclones Elegance LH Elisa Kit
FDA 510(k) K904387 · Bioclone Australia Pty , Ltd.
510(k) numberK904387
Submission
- Device name
- Bioclones Elegance LH Elisa Kit
- Applicant
- Bioclone Australia Pty , Ltd.
Washington, DC, US - Received
- September 25, 1990
- Decision date
- November 6, 1990
- 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 |
|---|---|---|
| K935049 | Elegance Neonatal TSH ElisaJLW · Traditional | 10/03/1994SE |
| K922284 | Elegance FT4 ElisaCEC · Traditional | 07/10/1992SE |
| K910419 | Bioclone's Elegance Ige Elisa KitDGC · Traditional | 06/21/1991SE |
| K910420 | Bioclone's Elegance HCG Elisa KitJHI · Traditional | 02/26/1991SE |
| K905099 | Elegance TSH ElisaJLW · Traditional | 12/18/1990SE |
| K905098 | Elegance GH ElisaCFL · Traditional | 12/06/1990SE |
| K904822 | Elegance Ferritin ElisaDBF · Traditional | 11/29/1990SE |
| K904483 | Elegance Prolactin ElisaCFT · Traditional | 11/05/1990SE |
| K904405 | Bioclones Elegance FSH Elisa KitCGJ · Traditional | 10/26/1990SE |
Questions and answers
When was Bioclones Elegance LH Elisa Kit cleared by the FDA?
Bioclones Elegance LH Elisa Kit (K904387) received a 510(k) decision of Substantially Equivalent on November 6, 1990, 42 days after the submission was received.
What is the product code of K904387?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.