The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier Chemstat.
Device ID | K183555 |
510k Number | K183555 |
Device Name: | GEM Premier ChemSTAT |
Classification | Enzymatic Method, Creatinine |
Applicant | Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
Contact | Gabriella Erdosy |
Correspondent | Gabriella Erdosy Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
Product Code | JFY |
Subsequent Product Code | CDQ |
Subsequent Product Code | KHS |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-20 |
Decision Date | 2019-02-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GEM PREMIER CHEMSTAT 86815492 not registered Live/Pending |
Instrumentation Laboratory Company 2015-11-10 |