The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Picoscal Blood Cell Counter Ps-4.
Device ID | K842140 |
510k Number | K842140 |
Device Name: | PICOSCAL BLOOD CELL COUNTER PS-4 |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKL |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-30 |
Decision Date | 1984-08-16 |