The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Lombard Dowell Agar Base.
Device ID | K864014 |
510k Number | K864014 |
Device Name: | LOMBARD DOWELL AGAR BASE |
Classification | Culture Media, Enriched |
Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
Contact | Gregg G Burmeister |
Correspondent | Gregg G Burmeister GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
Product Code | KZI |
CFR Regulation Number | 866.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-15 |
Decision Date | 1986-10-29 |