K840506 is an FDA 510(k) clearance for the HAEMOPHILUS INFLUENZAE TYPE B. This device is classified as a Neisseria Controls (Class I - General Controls, product code LSC).
Submitted by Scientific Device Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984, 58 days after receiving the submission on February 6, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K840506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1984 |
| Decision Date | April 04, 1984 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LSC — Neisseria Controls |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |