Genua Menopause Monitor Test Kit
FDA 510(k) K002450 · Genua 1944, Inc.
510(k) numberK002450
Submission
- Device name
- Genua Menopause Monitor Test Kit
- Applicant
- Genua 1944, Inc.
Blairstown, NJ, US - Received
- August 9, 2000
- Decision date
- January 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052662 | One Step FSH Menopausal TestCGJ · Traditional | Ind Diagnostic, Inc. | 11/30/2005SE |
| K043599 | Moments Menopause Check, Model 9113CGJ · Special | Phamatech, Inc. | 02/25/2005SE |
| K041165 | FSH Menopause Predictor TestCGJ · Traditional | ACON Laboratories, Inc. | 06/17/2004SE |
| K040575 | Pharmatech Menopause Check, Models 9111 and 9112CGJ · Traditional | Phamatech, Inc. | 05/20/2004SE |
| K030058 | Earlydetect Menopause Test for FSHCGJ · Traditional | Early Detect, Inc. | 07/30/2003SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | Monobind | 09/02/1997SE |
| K970085 | Sealite Sciences Aqualite FSHCGJ · Traditional | Sealite Sciences, Inc. | 02/14/1997SE |
| K964720 | Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)CGJ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/04/1997SE |
| K964693 | Elecsys FSH AssayCGJ · Traditional | Boehringer Mannheim Corp. | 12/16/1996SE |
| K962118 | DSL Active FSH IrmaCGJ · Traditional | Diagnostic Systems Laboratories, Inc. | 09/09/1996SE |
Questions and answers
When was Genua Menopause Monitor Test Kit cleared by the FDA?
Genua Menopause Monitor Test Kit (K002450) received a 510(k) decision of Substantially Equivalent on January 12, 2001, 156 days after the submission was received.
What is the product code of K002450?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.