The following data is part of a premarket notification filed by Thermo Fisher Scientific Inc. with the FDA for Qms Lidocaine.
| Device ID | K090282 |
| 510k Number | K090282 |
| Device Name: | QMS LIDOCAINE |
| Classification | Enzyme Immunoassay, Lidocaine |
| Applicant | THERMO FISHER SCIENTIFIC INC. 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis, IN 46268 -9046 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers THERMO FISHER SCIENTIFIC INC. 7998 GEORGETOWN ROAD SUITE 1000 Indianapolis, IN 46268 -9046 |
| Product Code | KLR |
| CFR Regulation Number | 862.3555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-05 |
| Decision Date | 2009-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883006072 | K090282 | 000 |