The following data is part of a premarket notification filed by Sensititre Microbiology A Div. Of Radiometer with the FDA for Gentamicin 500 Ug/ml To Be Included In Justone(tm).
| Device ID | K912613 |
| 510k Number | K912613 |
| Device Name: | GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | SENSITITRE MICROBIOLOGY A DIV. OF RADIOMETER 811 SHARON DR. Westlake, OH 44145 |
| Contact | Kathleen M Ontko |
| Correspondent | Kathleen M Ontko SENSITITRE MICROBIOLOGY A DIV. OF RADIOMETER 811 SHARON DR. Westlake, OH 44145 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-08-22 |