The following data is part of a premarket notification filed by Damon Corp. with the FDA for Iec Centra-7 Centrifuge Model 2362.
Device ID | K782124 |
510k Number | K782124 |
Device Name: | IEC CENTRA-7 CENTRIFUGE MODEL 2362 |
Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
Applicant | DAMON CORP. 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 | 1978-12-27 |
Decision Date | 1979-02-26 |