Ez Sure One Step Ovulation Predictor Home Test Kit
FDA 510(k) K970467 · Excel Scientific, Inc.
510(k) numberK970467
Submission
- Device name
- Ez Sure One Step Ovulation Predictor Home Test Kit
- Applicant
- Excel Scientific, Inc.
Yorba Linda, CA, US - Received
- February 7, 1997
- Decision date
- March 18, 1997
- 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 |
|---|---|---|
| K971286 | Ez Sure (Excel) Urine Midstream Pregnancy Home TestLCX · Traditional | 05/08/1997SE |
| K970425 | Ez Sure Urine Dipstick Pregnancy Home TestLCX · Traditional | 03/06/1997SE |
| K970424 | Excel One Step Urine HCG Pregnancy Dipstick TestJHI · Traditional | 03/06/1997SE |
| K963231 | Excel Onestep Urine HCG Module Pregnancy TestJHI · Traditional | 12/04/1996SE |
| K962146 | Excel Onestep Group a Strep Antigen Module Test KitGTZ · Traditional | 10/07/1996SE |
| K962580 | Ez Sure Onestep Early Pregnancy TestLCX · Traditional | 08/29/1996SE |
| K955707 | Onestep Urine/Serum HCG Module Pregnancy Test KitDHA · Traditional | 05/02/1996SE |
Questions and answers
When was Ez Sure One Step Ovulation Predictor Home Test Kit cleared by the FDA?
Ez Sure One Step Ovulation Predictor Home Test Kit (K970467) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 39 days after the submission was received.
What is the product code of K970467?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.