MODIFICA- OF EMIT CAD LIDOCAINE ASSAY
Enzyme Immunoassay, Lidocaine
SYVA CO.
The following data is part of a premarket notification filed by Syva Co. with the FDA for Modifica- Of Emit Cad Lidocaine Assay.
Pre-market Notification Details
| Device ID | K832799 |
| 510k Number | K832799 |
| Device Name: | MODIFICA- OF EMIT CAD LIDOCAINE ASSAY |
| Classification | Enzyme Immunoassay, Lidocaine |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLR |
| CFR Regulation Number | 862.3555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-18 |
| Decision Date | 1983-10-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|
| 00842768001390 |
K832799 |
000 |
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