K965190 is an FDA 510(k) clearance for the SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on March 19, 1997, 85 days after receiving the submission on December 24, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K965190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1996 |
| Decision Date | March 19, 1997 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JWY — Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |