The following data is part of a premarket notification filed by Alere San Diego, Incorporated with the FDA for Alere Signify H. Pylori Whole Blood, Serum, Plasma; Alere Signify H. Pylori Whole Blood Only;alere Clearview H. Pylori Whole Blood, Serum, Plasma; Alere Clearview H. Pylori Whole Blood Only.
| Device ID | K151935 |
| 510k Number | K151935 |
| Device Name: | Alere Signify H. Pylori Whole Blood, Serum, Plasma; Alere Signify H. Pylori Whole Blood Only;Alere Clearview H. Pylori Whole Blood, Serum, Plasma; Alere Clearview H. Pylori Whole Blood Only |
| Classification | Helicobacter Pylori |
| Applicant | ALERE SAN DIEGO, INCORPORATED 9975 SUMMERS RIDGE ROAD San Diego, CA 92121 |
| Contact | Joseph De La Rosa |
| Correspondent | Joseph De La Rosa ALERE SAN DIEGO, INCORPORATED 9975 SUMMERS RIDGE ROAD San Diego, CA 92121 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2015-08-12 |
| Summary: | summary |