The following data is part of a premarket notification filed by Sensititre Microbiology A Div. Of Radiometer with the FDA for Hp-haemophilus/pneumococcus Mic Plate.
| Device ID | K912778 |
| 510k Number | K912778 |
| Device Name: | HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | SENSITITRE MICROBIOLOGY A DIV. OF RADIOMETER 811 SHARON DR. Westlake, OH 44145 |
| Contact | Kathleen Ontko |
| Correspondent | Kathleen 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 | 1991-06-24 |
| Decision Date | 1992-02-18 |