The following data is part of a premarket notification filed by Microtech Medical Systems, Inc. with the FDA for Mic-concept System.
| Device ID | K852613 |
| 510k Number | K852613 |
| Device Name: | MIC-CONCEPT SYSTEM |
| Classification | Susceptibility Test Cards, Antimicrobial |
| Applicant | MICROTECH MEDICAL SYSTEMS, INC. 401 LAREDO ST., UNIT 1 Aurora, CO 80011 |
| Contact | Jerry G Kilgore |
| Correspondent | Jerry G Kilgore MICROTECH MEDICAL SYSTEMS, INC. 401 LAREDO ST., UNIT 1 Aurora, CO 80011 |
| Product Code | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-19 |
| Decision Date | 1985-09-20 |