The following data is part of a premarket notification filed by Shotwell & Carr, Inc. with the FDA for Mdx 2000, Digital Analyzer.
| Device ID | K970824 |
| 510k Number | K970824 |
| Device Name: | MDX 2000, DIGITAL ANALYZER |
| Classification | Device, Automated Cell-locating |
| Applicant | SHOTWELL & CARR, INC. 3003 LBJ FREEWAY, SUITE 100 Dallas, TX 75234 -7755 |
| Contact | Bert Hudson |
| Correspondent | Bert Hudson SHOTWELL & CARR, INC. 3003 LBJ FREEWAY, SUITE 100 Dallas, TX 75234 -7755 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-06 |
| Decision Date | 1997-05-30 |
| Summary: | summary |