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 |