The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Ana Trans Tube & Swabs Sterile Pack.
Device ID | K834357 |
510k Number | K834357 |
Device Name: | ANA TRANS TUBE & SWABS STERILE PACK |
Classification | Culture Media, Anaerobic Transport |
Applicant | ANAEROBE SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSL |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-13 |
Decision Date | 1984-01-31 |