The following data is part of a premarket notification filed by Drew Scientific, Inc. with the FDA for Trilogy Analyzer.
| Device ID | K070704 |
| 510k Number | K070704 |
| Device Name: | TRILOGY ANALYZER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | DREW SCIENTIFIC, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia Sinclair |
| Correspondent | Cynthia Sinclair DREW SCIENTIFIC, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | CGA |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-13 |
| Decision Date | 2007-07-13 |
| Summary: | summary |