Modification of Clearplan Easy Fertility Monitor
FDA 510(k) K990223 · Unipath , Ltd.
510(k) numberK990223
Submission
- Device name
- Modification of Clearplan Easy Fertility Monitor
- Applicant
- Unipath , Ltd.
Bedford, GB - Received
- January 25, 1999
- Decision date
- February 24, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K850579 | Cue Fertility MonitorNGE · Traditional | Zetek, Inc. | 03/22/1985SE |
More from Zetek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061769 | E.P.T. Certainty 1-STEP Pregnancy TestLCX · Special | 07/03/2006SE |
| K060128 | Clearblue Easy Digital Pregnancy TestLCX · Traditional | 05/25/2006SE |
| K051638 | Inverness Medical Testpack + Plus Strep a with ObcGTY · Traditional | 12/06/2005SE |
| K050930 | E.P.T. Certainty Pregnancy TestLCX · Special | 05/12/2005SE |
| K042280 | Fact Plus One-Step Pregnancy Test KitLCX · Special | 09/10/2004SE |
| K041404 | Clearblue Easy Easy Read Pregnancy TestLCX · Special | 06/08/2004SE |
| K040341 | Clearblue Easy Earliest Results Pregnancy TestLCX · Special | 03/08/2004SE |
| K040329 | Modification to E.P.T. Pregnancy TestLCX · Special | 03/08/2004SE |
| K033658 | E.P.T. Pregnancy TestLCX · Special | 01/16/2004SE |
| K032939 | Ept Certainty Pregnancy TestLCX · Special | 10/20/2003SE |
Questions and answers
When was Modification of Clearplan Easy Fertility Monitor cleared by the FDA?
Modification of Clearplan Easy Fertility Monitor (K990223) received a 510(k) decision of Substantially Equivalent on February 24, 1999, 30 days after the submission was received.
What is the product code of K990223?
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.