The following data is part of a premarket notification filed by Bioprobe Intl., Inc. with the FDA for Bioprobe Fluor Gentamicin In Serum Or Plasma.
| Device ID | K852158 |
| 510k Number | K852158 |
| Device Name: | BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA |
| Classification | Fluorescent Immunoassay Gentamicin |
| Applicant | BIOPROBE INTL., INC. 2842 WALNUT AVE., SUITE C Tustin, CA 92680 |
| Contact | Perry G Rucker |
| Correspondent | Perry G Rucker BIOPROBE INTL., INC. 2842 WALNUT AVE., SUITE C Tustin, CA 92680 |
| Product Code | LCQ |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-17 |
| Decision Date | 1985-06-25 |