The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Counter-check Plus Normal, High Abn..
Device ID | K791772 |
510k Number | K791772 |
Device Name: | COUNTER-CHECK PLUS NORMAL, HIGH ABN. |
Classification | Mixture, Hematology Quality Control |
Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JPK |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-07 |
Decision Date | 1979-10-11 |