K834412 is an FDA 510(k) clearance for the PRESERV PVA FIXATIVE 15ML-FORMALIN PK. This device is classified as a Container, Specimen Mailer And Storage, Sterile (Class I - General Controls, product code KDT).
Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984, 29 days after receiving the submission on December 15, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K834412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1983 |
| Decision Date | January 13, 1984 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KDT — Container, Specimen Mailer And Storage, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3250 |