The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Campylobacter Selective Supple-blaser.
Device ID | K833019 |
510k Number | K833019 |
Device Name: | CAMPYLOBACTER SELECTIVE SUPPLE-BLASER |
Classification | Supplement, Culture Media |
Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSK |
CFR Regulation Number | 866.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-06 |
Decision Date | 1983-10-14 |