The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Couiter/cms Isotonic Blood Bank Saline.
| Device ID | K792101 |
| 510k Number | K792101 |
| Device Name: | COUITER/CMS ISOTONIC BLOOD BANK SALINE |
| Classification | Solution, Isotonic |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCE |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-19 |
| Decision Date | 1979-11-20 |