The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Refrig. Centrifuge (drucker Model).
| Device ID | K800381 |
| 510k Number | K800381 |
| Device Name: | REFRIG. CENTRIFUGE (DRUCKER MODEL) |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | COULTER ELECTRONICS, 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 | 1980-02-22 |
| Decision Date | 1980-03-19 |