The following data is part of a premarket notification filed by Tekpro with the FDA for Rh Viewbox.
Device ID | K792306 |
510k Number | K792306 |
Device Name: | RH VIEWBOX |
Classification | Boxes, View, Blood Grouping |
Applicant | TEKPRO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KSY |
CFR Regulation Number | 864.9185 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-16 |
Decision Date | 1979-12-04 |