Lee-Bead Beta FSH (Eia)
FDA 510(k) K854837 · Leeco Diagnostics, Inc.
510(k) numberK854837
Submission
- Device name
- Lee-Bead Beta FSH (Eia)
- Applicant
- Leeco Diagnostics, Inc.
Southfield, MI, US - Received
- December 3, 1985
- Decision date
- January 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
| K002450 | Genua Menopause Monitor Test KitCGJ · Traditional | Genua 1944, Inc. | 01/12/2001SE |
| 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 |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K895765 | Leeco Preview(R) Ebv (Eia)KTN · Traditional | 10/31/1989SE |
| K894122 | Leeco Vis-Disk Strep-A (Eia)GTZ · Traditional | 08/15/1989SE |
| K891096 | Vis-Disk HCG (Eia) JPL-041MDHA · Traditional | 06/16/1989SE |
| K891095 | Vis-Disk HCG (Eia) Lyophilized JPL-044MDHA · Traditional | 06/16/1989SE |
| K883269 | Prl-QuantCFT · Traditional | 09/13/1988SE |
| K880577 | CONCEP-7-BHCGJHI · Traditional | 03/15/1988SE |
| K880069 | Leeco Pregnastick (Eia) Catalog #003LCX · Traditional | 02/11/1988SE |
| K870259 | Vis-Cube HCG (Eia) Lyophilized JPL-044JHI · Traditional | 03/10/1987SE |
| K864170 | Leeco Vis-Cube Strep a (Eia)GTZ · Traditional | 02/03/1987SE |
| K863999 | Vis-Cube Pregnancy Home Test,Cat. # JPL-042LCX · Traditional | 01/09/1987SE |
Questions and answers
When was Lee-Bead Beta FSH (Eia) cleared by the FDA?
Lee-Bead Beta FSH (Eia) (K854837) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 41 days after the submission was received.
What is the product code of K854837?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.