Conceive Ovulation Predictor
FDA 510(k) K953063 · Quidel Corp.
510(k) numberK953063
Submission
- Device name
- Conceive Ovulation Predictor
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- June 30, 1995
- Decision date
- August 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K231795 | QuickVue COVID-19 TestQYT · Traditional | 03/22/2024SE |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentPGI · Traditional | 12/20/2023SE |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF · Special | 12/13/2023SE |
| K230349 | Lyra RSV+hMPV AssayOEM · Special | 03/10/2023SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | 03/03/2023SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | 11/23/2021SE |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR · Dual Track | 08/30/2018SE |
| K181029 | Solana Bordetella Complete AssayOZZ · Traditional | 07/15/2018SE |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | 02/28/2018SE |
| K180288 | QuickVue Influenza A+BPSZ · Special | 02/13/2018SE |
Questions and answers
When was Conceive Ovulation Predictor cleared by the FDA?
Conceive Ovulation Predictor (K953063) received a 510(k) decision of Substantially Equivalent on August 23, 1995, 54 days after the submission was received.
What is the product code of K953063?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.