The following data is part of a premarket notification filed by Zetek, Inc. with the FDA for Cue Fertility Monitor.
| Device ID | K850579 |
| 510k Number | K850579 |
| Device Name: | CUE FERTILITY MONITOR |
| Classification | Test, Luteinizing Hormone (lh), Over The Counter |
| Applicant | ZETEK, INC. BURDITT, BOWLES & RADZIUS, LTD 135 SOUTH LA SALLE STREET Chicago, IL 60603 |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius ZETEK, INC. BURDITT, BOWLES & RADZIUS, LTD 135 SOUTH LA SALLE STREET Chicago, IL 60603 |
| Product Code | NGE |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-13 |
| Decision Date | 1985-03-22 |