Ovuquick Self-Test (Ovuquick; Ramp LH Assay)
FDA 510(k) K871726 · Monoclonal Antibodies, Inc.
510(k) numberK871726
Submission
- Device name
- Ovuquick Self-Test (Ovuquick; Ramp LH Assay)
- Applicant
- Monoclonal Antibodies, Inc.
Mountain View, CA, US - Received
- May 5, 1987
- Decision date
- July 27, 1987
- 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 |
|---|---|---|
| K874863 | Ramp Herpes Simplex Virus (HSV) (CCT)GQN · Traditional | 02/16/1988SE |
| K863744 | HCG Control KitJJX · Traditional | 11/05/1986SE |
| K860924 | Ramp Progesturine PDG ASSAY--48 Test KitJLS · Traditional | 07/02/1986SE |
| K854611 | Ramp Urine HCG AssayJHI · Traditional | 12/30/1985SE |
| K850730 | Model Serum HCG AssayJHI · Traditional | 04/02/1985SE |
| K850480 | Ovu Stick Self-Test -ModificationCEP · Traditional | 03/05/1985SE |
| K843284 | Ovustick Self-TestCEP · Traditional | 12/11/1984SE |
| K840738 | Plus Urine HCG AssayJHJ · Traditional | 04/19/1984SE |
| K840412 | Ovu Stick Urine HLH KitCEP · Traditional | 04/13/1984SE |
| K833504 | Pregnastick Urine HCG KitJHJ · Traditional | 01/09/1984SE |
Questions and answers
When was Ovuquick Self-Test (Ovuquick; Ramp LH Assay) cleared by the FDA?
Ovuquick Self-Test (Ovuquick; Ramp LH Assay) (K871726) received a 510(k) decision of Substantially Equivalent on July 27, 1987, 83 days after the submission was received.
What is the product code of K871726?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.