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 |