The following data is part of a premarket notification filed by V-tech, Inc. with the FDA for Target Reader.
| Device ID | K885254 |
| 510k Number | K885254 |
| Device Name: | TARGET READER |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | V-TECH, INC. 270 E. BONITA AVE. Pomona, CA 91767 |
| Contact | Willa Brunkhorst |
| Correspondent | Willa Brunkhorst V-TECH, INC. 270 E. BONITA AVE. Pomona, CA 91767 |
| Product Code | JQT |
| CFR Regulation Number | 862.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-23 |
| Decision Date | 1989-01-27 |