The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Lh Ovulation Predicting Test.
| Device ID | K022829 |
| 510k Number | K022829 |
| Device Name: | INSTANT-VIEW LH OVULATION PREDICTING TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-26 |
| Decision Date | 2002-11-05 |
| Summary: | summary |