The following data is part of a premarket notification filed by Microtest with the FDA for M4-rt Transport Medium, (m4 Modification).
Device ID | K921472 |
510k Number | K921472 |
Device Name: | M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION) |
Classification | Culture Media, Non-propagating Transport |
Applicant | MICROTEST 1379 BRENTFORD COVE Snelleville, GA 30278 |
Contact | James P Brinker |
Correspondent | James P Brinker MICROTEST 1379 BRENTFORD COVE Snelleville, GA 30278 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-19 |
Decision Date | 1992-05-06 |