K792101 is an FDA 510(k) clearance for the COUITER/CMS ISOTONIC BLOOD BANK SALINE. This device is classified as a Solution, Isotonic (Class I - General Controls, product code JCE).
Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979, 32 days after receiving the submission on October 19, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K792101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1979 |
| Decision Date | November 20, 1979 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JCE — Solution, Isotonic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |