Lumatag(Tm) LH Diagnostic Kit
FDA 510(k) K902443 · London Diagnostics, Inc.
510(k) numberK902443
Submission
- Device name
- Lumatag(Tm) LH Diagnostic Kit
- Applicant
- London Diagnostics, Inc.
Eden Prairie, MN, US - Received
- June 1, 1990
- Decision date
- August 2, 1990
- 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 |
|---|---|---|
| K914835 | Lumatag Free T4 Chemiluminescence AssayCEC · Traditional | 12/17/1991SE |
| K911985 | Lumatag T4 Chemiluminescence AssayCDX · Traditional | 08/02/1991SE |
| K912858 | London Diagnostics Lumatag(R) HGH Chem Immun AssayCFL · Traditional | 07/30/1991SE |
| K905814 | Lumatag(R) FSH Chemiluminescence Immunometri AssayCGJ · Traditional | 02/04/1991SE |
| K904458 | Lumatag(Tm) Prolactin Diagnostic Kit/ModificationCFT · Traditional | 10/12/1990SE |
| K903130 | London Diagnostics Lumatag(Tm) Intact PTH AssayCEW · Traditional | 09/25/1990SE |
| K903195 | London Diagnostics Lumatag (R) Ige Chem. Imm AssayDGC · Traditional | 08/02/1990SE |
| K901484 | Lumatag(Tm) HCG Chemiluminescence ImmunometricJHI · Traditional | 05/01/1990SE |
| K901075 | Lumatag(Tm) Ferritin Chemiluminescence Immunomet.DBF · Traditional | 04/02/1990SE |
| K881443 | Lumatag(Tm) TSH Chemiluminescence Immuno. AssayJLW · Traditional | 05/27/1988SE |
Questions and answers
When was Lumatag(Tm) LH Diagnostic Kit cleared by the FDA?
Lumatag(Tm) LH Diagnostic Kit (K902443) received a 510(k) decision of Substantially Equivalent on August 2, 1990, 62 days after the submission was received.
What is the product code of K902443?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.