The following data is part of a premarket notification filed by Tahoe Chemical R & D with the FDA for Device, Blood Mixing And Weighing.
Device ID | BK970012 |
510k Number | BK970012 |
Device Name: | Device, Blood Mixing And Weighing |
Classification | Device, Blood Mixing And Blood Weighing |
Applicant | Tahoe Chemical R & D 2230 Damon Road Carson City, NV 89701 US |
Product Code | KSQ |
CFR Regulation Number | 864.9195 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-20 |
Decision Date | 1997-07-14 |