The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Group Strep Broth T3472 Lim.
Device ID | K833759 |
510k Number | K833759 |
Device Name: | GROUP STREP BROTH T3472 LIM |
Classification | Culture Media, Selective Broth |
Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSD |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-26 |
Decision Date | 1983-12-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382902962664 | K833759 | 000 |