The following data is part of a premarket notification filed by International Equipment Co. with the FDA for Iec Centra 4 Centrifuge.
Device ID | K821756 |
510k Number | K821756 |
Device Name: | IEC CENTRA 4 CENTRIFUGE |
Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
Applicant | INTERNATIONAL EQUIPMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQC |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-15 |
Decision Date | 1982-06-25 |