The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Gentamicin Assay.
| Device ID | K940376 |
| 510k Number | K940376 |
| Device Name: | QMS GENTAMICIN ASSAY |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Andris Indriksons |
| Correspondent | Andris Indriksons SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-26 |
| Decision Date | 1994-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012677 | K940376 | 000 |
| 00884883011205 | K940376 | 000 |