The following data is part of a premarket notification filed by Iso-data, Inc. with the FDA for Iso-data Centrifuges 1-a, 101, 2d, Etc..
| Device ID | K843434 |
| 510k Number | K843434 |
| Device Name: | ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | ISO-DATA, INC. 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 | 1984-09-04 |
| Decision Date | 1984-10-05 |