The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Martin-lewis Agar Medium.
Device ID | K770287 |
510k Number | K770287 |
Device Name: | MARTIN-LEWIS AGAR MEDIUM |
Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTY |
CFR Regulation Number | 866.2410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-14 |
Decision Date | 1977-02-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382902215579 | K770287 | 000 |
30382902215586 | K770287 | 000 |