The following data is part of a premarket notification filed by Heraeus Inc. with the FDA for Centrifuge, Blood Bank For In Vitro Diagnostic Use.
Device ID | BK900024 |
510k Number | BK900024 |
Device Name: | Centrifuge, Blood Bank For In Vitro Diagnostic Use |
Classification | Centrifuge, Blood-bank For In Vitro Diagnostic Use |
Applicant | Heraeus Inc. 111a Corporate Blvd, S. Plainfield, NJ 07080 |
Product Code | KSO |
CFR Regulation Number | 864.9275 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-15 |
Decision Date | 1992-11-05 |