The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Amikacin Mab.
| Device ID | K991597 |
| 510k Number | K991597 |
| Device Name: | COBAS INTEGRA AMIKACIN MAB |
| Classification | Fluorescence Polarization Immunoassay, Amibacin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Lisa Gerard |
| Correspondent | Lisa Gerard ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | LGJ |
| CFR Regulation Number | 862.3035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-07-22 |
| Summary: | summary |