The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Unilab Culturing Set.
Device ID | K792648 |
510k Number | K792648 |
Device Name: | UNILAB CULTURING SET |
Classification | Indicator, Biological Sterilization Process |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRC |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-21 |
Decision Date | 1980-02-06 |