Cue Fertility Monitor
FDA 510(k) K850579 · Zetek, Inc.
510(k) numberK850579
Submission
- Device name
- Cue Fertility Monitor
- Applicant
- Zetek, Inc.
Chicago, IL, US - Received
- February 13, 1985
- Decision date
- March 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NGE – Test, Luteinizing Hormone (Lh), Over The Counter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020808 | Fertilite OvNGE · Traditional | Pheromone Sciences Corp. | 09/23/2002SE |
| K990223 | Modification of Clearplan Easy Fertility MonitorNGE · Special | Unipath , Ltd. | 02/24/1999SE |
| K981207 | Clearplan Easy Fertility MonitorNGE · Traditional | Unipath , Ltd. | 10/28/1998SE |
| K973860 | Ovulon MonitorNGE · Traditional | Conception Technology, Inc. | 01/07/1998SE |
| K863121 | Peak Ovulation PredictorNGE · Traditional | Micron Technology, Inc. | 10/14/1986SE |
Questions and answers
When was Cue Fertility Monitor cleared by the FDA?
Cue Fertility Monitor (K850579) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 37 days after the submission was received.
What is the product code of K850579?
The FDA product code is NGE – Test, Luteinizing Hormone (Lh), Over The Counter, a Class I (low risk) device regulated under 21 CFR 862.1485.