REPLIANALYZER
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
MCT MEDICAL, INC.
The following data is part of a premarket notification filed by Mct Medical, Inc. with the FDA for Replianalyzer.
Pre-market Notification Details
| Device ID | K861958 |
| 510k Number | K861958 |
| Device Name: | REPLIANALYZER |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | MCT MEDICAL, INC. 1997 SLOAN PLACE SUITE 26 St. Paul, MN 55117 |
| Contact | Ann Weaver |
| Correspondent | Ann Weaver MCT MEDICAL, INC. 1997 SLOAN PLACE SUITE 26 St. Paul, MN 55117 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-08-01 |
Trademark Results [REPLIANALYZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REPLIANALYZER 73733025 1551680 Dead/Cancelled |
MCT MEDICAL INC. 1988-06-07 |
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