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 |