The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Laser-cal.
| Device ID | K811063 |
| 510k Number | K811063 |
| Device Name: | LASER-CAL |
| Classification | Calibrator For Cell Indices |
| Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRX |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-17 |
| Decision Date | 1981-07-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LASER-CAL 73323471 1254174 Dead/Cancelled |
Diagnostic Technology, Inc. 1981-08-13 |