The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Quik-check Ovulation Predictor.
| Device ID | K012252 |
| 510k Number | K012252 |
| Device Name: | QUIK-CHECK OVULATION PREDICTOR |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | ACON LABORATORIES, INC. 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White ACON LABORATORIES, INC. 163 CABOT ST. Beverly, MA 01915 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-18 |
| Decision Date | 2001-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50096295133207 | K012252 | 000 |