Inverness Medical Ovulation Predictor Test
FDA 510(k) K002867 · Selfcare, Inc.
510(k) numberK002867
Submission
- Device name
- Inverness Medical Ovulation Predictor Test
- Applicant
- Selfcare, Inc.
Waltham, MA, US - Received
- September 13, 2000
- Decision date
- October 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K990249 | Ovustick LH Ovulation Predictor, Model 9030, Ovucard LH Ovulation Predictor, Model 9031CEP · Traditional | Phamatech | 03/22/1999SE |
More from Phamatech
| 510(k) | Device | Decision |
|---|---|---|
| K002134 | One Touch Ultra Blood Glucose Monitoring SystemCGA · Special | 08/07/2000SE |
| K002049 | Inverness Medical Early Pregnancy TestLCX · Special | 07/27/2000SE |
| K001427 | Modification to Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 06/02/2000SE |
| K000583 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 03/17/2000SE |
| K993632 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 11/12/1999SE |
| K991480 | Excel GE Blood Glucose Test Strips & Code StripCGA · Traditional | 09/17/1999SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | 05/25/1999SE |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | 05/25/1999SE |
| K990939 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 04/20/1999SE |
| K983468 | Fasttake Adapter, Model # P/N 020-072-01JQP · Traditional | 12/17/1998SE |
Questions and answers
When was Inverness Medical Ovulation Predictor Test cleared by the FDA?
Inverness Medical Ovulation Predictor Test (K002867) received a 510(k) decision of Substantially Equivalent on October 12, 2000, 29 days after the submission was received.
What is the product code of K002867?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.