The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Qms Lidocaine Calibrators, Model 0374678.
Device ID | K091617 |
510k Number | K091617 |
Device Name: | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 |
Classification | Calibrators, Drug Specific |
Applicant | Thermo Fisher Scientific 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis, IN 46268 |
Contact | Jack Rogers |
Correspondent | Jack Rogers Thermo Fisher Scientific 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis, IN 46268 |
Product Code | DLJ |
CFR Regulation Number | 862.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-03 |
Decision Date | 2009-07-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884883000704 | K091617 | 000 |