The following data is part of a premarket notification filed by Microtest with the FDA for Modified Micro Test Multi Microbe Medium (m5).
Device ID | K941579 |
510k Number | K941579 |
Device Name: | MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5) |
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 | 1994-04-01 |
Decision Date | 1994-10-21 |