The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Preserv Transport & Culture Pack.
Device ID | K840968 |
510k Number | K840968 |
Device Name: | PRESERV TRANSPORT & CULTURE PACK |
Classification | System, Transport, Aerobic |
Applicant | PREVENTIVE DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTW |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-06 |
Decision Date | 1984-03-23 |