K844877 is an FDA 510(k) clearance for the HEPES BUFFER IM IN NORMAL SALINE. This device is classified as a Formulations, Balanced Salt Solutions (Class I - General Controls, product code KIP).
Submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on February 25, 1985, 70 days after receiving the submission on December 17, 1984.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2875.
| 510(k) Number | K844877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1984 |
| Decision Date | February 25, 1985 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIP — Formulations, Balanced Salt Solutions |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2875 |