Clearplan Easy
FDA 510(k) K894579 · Unipath , Ltd.
510(k) numberK894579
Submission
- Device name
- Clearplan Easy
- Applicant
- Unipath , Ltd.
Bedford Mk41 Oqg, GB - Received
- July 24, 1989
- Decision date
- October 12, 1989
- 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
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| 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 |
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| 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 cleared by the FDA?
Clearplan Easy (K894579) received a 510(k) decision of Substantially Equivalent on October 12, 1989, 80 days after the submission was received.
What is the product code of K894579?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.