Clearplan Easy Ovulation Test
FDA 510(k) K981271 · Unipath , Ltd.
510(k) numberK981271
Submission
- Device name
- Clearplan Easy Ovulation Test
- Applicant
- Unipath , Ltd.
Bedford, GB - Received
- April 7, 1998
- Decision date
- June 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K061769 | E.P.T. Certainty 1-STEP Pregnancy TestLCX · Special | 07/03/2006SE |
| K060128 | Clearblue Easy Digital Pregnancy TestLCX · Traditional | 05/25/2006SE |
| K051638 | Inverness Medical Testpack + Plus Strep a with ObcGTY · Traditional | 12/06/2005SE |
| K050930 | E.P.T. Certainty Pregnancy TestLCX · Special | 05/12/2005SE |
| K042280 | Fact Plus One-Step Pregnancy Test KitLCX · Special | 09/10/2004SE |
| K041404 | Clearblue Easy Easy Read Pregnancy TestLCX · Special | 06/08/2004SE |
| K040341 | Clearblue Easy Earliest Results Pregnancy TestLCX · Special | 03/08/2004SE |
| K040329 | Modification to E.P.T. Pregnancy TestLCX · Special | 03/08/2004SE |
| K033658 | E.P.T. Pregnancy TestLCX · Special | 01/16/2004SE |
| K032939 | Ept Certainty Pregnancy TestLCX · Special | 10/20/2003SE |
Questions and answers
When was Clearplan Easy Ovulation Test cleared by the FDA?
Clearplan Easy Ovulation Test (K981271) received a 510(k) decision of Substantially Equivalent on June 25, 1998, 79 days after the submission was received.
What is the product code of K981271?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.