The following data is part of a premarket notification filed by Microtech Medical Systems, Inc. with the FDA for Mic - Concept(tm) Rx-2.
| Device ID | K863847 |
| 510k Number | K863847 |
| Device Name: | MIC - CONCEPT(TM) RX-2 |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| 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 | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-12-18 |