Submission Details
| 510(k) Number | K833027 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 1983 |
| Decision Date | October 28, 1983 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K833027 is an FDA 510(k) clearance for the HAEMOPHILUS/NEISSERIA IDENTIF-PANEL, submitted by American Micro Scan (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 51 days after receiving the submission on September 7, 1983. This device falls under the Microbiology review panel.
| 510(k) Number | K833027 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 1983 |
| Decision Date | October 28, 1983 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | — |
| Device Class | — |