The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Counter Check, H001, H002, H003.
Device ID | K790025 |
510k Number | K790025 |
Device Name: | COUNTER CHECK, H001, H002, H003 |
Classification | Kit, Quality Control For Blood Banking Reagents |
Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KSF |
CFR Regulation Number | 864.9650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-03 |
Decision Date | 1979-01-17 |