The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Preserv Pva Fixative -malin Pack.
| Device ID | K833660 |
| 510k Number | K833660 |
| Device Name: | PRESERV PVA FIXATIVE -MALIN PACK |
| Classification | Container, Specimen Mailer And Storage, Sterile |
| Applicant | PREVENTIVE DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDT |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-18 |
| Decision Date | 1983-11-28 |