The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Selective Legionella Media.
Device ID | K823885 |
510k Number | K823885 |
Device Name: | SELECTIVE LEGIONELLA MEDIA |
Classification | Culture Media, Selective And Non-differential |
Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-27 |
Decision Date | 1983-03-08 |