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 |