The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for At Home Ovulation Test, Model 9032.
| Device ID | K021409 |
| 510k Number | K021409 |
| Device Name: | AT HOME OVULATION TEST, MODEL 9032 |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | PHAMATECH INC. 9530 PADGETT ST., #101-106 San Diego, CA 92126 |
| Contact | Carl A Mongiovi |
| Correspondent | Carl A Mongiovi PHAMATECH INC. 9530 PADGETT ST., #101-106 San Diego, CA 92126 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-03 |
| Decision Date | 2002-05-24 |
| Summary: | summary |