K895187 is an FDA 510(k) clearance for the FDL, INC.'S TRANSPORT SYSTEM. This device is classified as a System, Transport, Aerobic (Class I - General Controls, product code JTW).
Submitted by Fairleigh Dickinson Laboratories, Inc. (Abilene, US). The FDA issued a Cleared decision on October 24, 1989, 74 days after receiving the submission on August 11, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K895187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1989 |
| Decision Date | October 24, 1989 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTW — System, Transport, Aerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |