The following data is part of a premarket notification filed by Heraeus-christ Gmbh with the FDA for Centrifuges.
Device ID | K840768 |
510k Number | K840768 |
Device Name: | CENTRIFUGES |
Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
Applicant | HERAEUS-CHRIST GMBH 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JQC |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-23 |
Decision Date | 1984-05-07 |