Miniclinic Ovulation Prediction Test
FDA 510(k) K891762 · Vanguard Biomedical Corp.
510(k) numberK891762
Submission
- Device name
- Miniclinic Ovulation Prediction Test
- Applicant
- Vanguard Biomedical Corp.
San Diego, CA, US - Received
- March 24, 1989
- Decision date
- July 20, 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
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 |
|---|---|---|
| K960733 | Ministick Pregnancy TestLCX · Traditional | 05/01/1996SE |
| K960233 | Miniclinic Ovulation PredictorCEP · Traditional | 04/23/1996SE |
| K930014 | Proclinic One-Step Dipstick Pregnancy TestJHI · Traditional | 03/25/1993SE |
| K914254 | Homeclinic One Step Pregnancy TestLCX · Traditional | 10/17/1991SE |
| K914253 | Proclinic One Step Pregnancy TestJHI · Traditional | 10/11/1991SE |
| K910351 | Miniclinic Ovulation Prediction TestCEP · Traditional | 03/21/1991SE |
| K895560 | Modified Homeclinic Pregnancy TestLCX · Traditional | 11/13/1989SE |
| K894012 | Miniclinic Pregnancy TestJHI · Traditional | 07/25/1989SE |
| K883826 | Home Clinic Pregnancy TestLCX · Traditional | 11/29/1988SE |
Questions and answers
When was Miniclinic Ovulation Prediction Test cleared by the FDA?
Miniclinic Ovulation Prediction Test (K891762) received a 510(k) decision of Substantially Equivalent on July 20, 1989, 118 days after the submission was received.
What is the product code of K891762?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.