K840991 is an FDA 510(k) clearance for the PRESERV BUFFERED GLYCEROL SALINE. This device is classified as a System, Transport, Aerobic (Class I - General Controls, product code JTW).
Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 16 days after receiving the submission on March 7, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K840991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1984 |
| Decision Date | March 23, 1984 |
| Days to Decision | 16 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 |