The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Plate, Ld Presumpto.
Device ID | K781856 |
510k Number | K781856 |
Device Name: | PLATE, LD PRESUMPTO |
Classification | Culture Media, Multiple Biochemical Test |
Applicant | ANAEROBE SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSE |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-06 |
Decision Date | 1978-11-22 |