K894216 is an FDA 510(k) clearance for the HAEMOPHILUS TEST MEDIUM (HTM)AGAR. This device is classified as a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II - Special Controls, product code JSO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 13, 1989, 177 days after receiving the submission on June 19, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1700.
| 510(k) Number | K894216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1989 |
| Decision Date | December 13, 1989 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1700 |