Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick)
FDA 510(k) K991386 · Selfcare, Inc.
510(k) numberK991386
Submission
- Device name
- Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick)
- Applicant
- Selfcare, Inc.
Waltham, MA, US - Received
- April 21, 1999
- Decision date
- May 25, 1999
- 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 |
| 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 |
|---|---|---|
| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | 10/12/2000SE |
| 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 |
| 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 Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick) cleared by the FDA?
Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick) (K991386) received a 510(k) decision of Substantially Equivalent on May 25, 1999, 34 days after the submission was received.
What is the product code of K991386?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.