The following data is part of a premarket notification filed by Alpco with the FDA for Alpco Calprotectin Chemiluminescence Elisa, Alpco Easy Stool Extraction Device.
| Device ID | K191807 |
| 510k Number | K191807 |
| Device Name: | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device |
| Classification | Calprotectin, Fecal |
| Applicant | ALPCO 26 Keewaydin Drive, Unit G Salem, NH 03079 |
| Contact | Jeffrey Freedman |
| Correspondent | Jeffrey Freedman ALPCO 26 Keewaydin Drive, Unit G Salem, NH 03079 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-05 |
| Decision Date | 2019-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B24280CALPHUCH010 | K191807 | 000 |
| B24280CALPHUCH500 | K191807 | 000 |