Submission Details
| 510(k) Number | K020808 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 2002 |
| Decision Date | September 23, 2002 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
FERTILITE OV
Sep 2002
Decision
195d
Days
Class 1
Risk
About This 510(k) Submission
K020808 is an FDA 510(k) clearance for the FERTILITE OV, a Test, Luteinizing Hormone (lh), Over The Counter (Class I — General Controls, product code NGE), submitted by Pheromone Sciences Corp. (Toronto, CA). The FDA issued a Cleared decision on September 23, 2002, 195 days after receiving the submission on March 12, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1485.
Device Classification
| Product Code | NGE — Test, Luteinizing Hormone (lh), Over The Counter |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1485 |
Manufacturer
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