The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bac-t-screen.
Device ID | K833917 |
510k Number | K833917 |
Device Name: | BAC-T-SCREEN |
Classification | Monitor, Microbial Growth |
Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTA |
CFR Regulation Number | 866.2560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-14 |
Decision Date | 1984-01-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BAC-T-SCREEN 73418323 1299329 Dead/Cancelled |
Marion Laboratories, Inc. 1983-03-22 |