The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Pdc 104 Single Swab Culture Collection.
Device ID | K791924 |
510k Number | K791924 |
Device Name: | PDC 104 SINGLE SWAB CULTURE COLLECTION |
Classification | System, Transport, Aerobic |
Applicant | PRECISION DYNAMICS 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 | 1979-09-27 |
Decision Date | 1979-10-17 |