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 |