The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Mueller Hinton Agar W/oxacillin.
Device ID | K941985 |
510k Number | K941985 |
Device Name: | MUELLER HINTON AGAR W/OXACILLIN |
Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P O BOX 1328 Stone Mountain, GA 30086 |
Contact | Leslie C Scarborough,jr |
Correspondent | Leslie C Scarborough,jr CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P O BOX 1328 Stone Mountain, GA 30086 |
Product Code | JTZ |
CFR Regulation Number | 866.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-25 |
Decision Date | 1994-08-24 |