K812309 is an FDA 510(k) clearance for the CRYOSAN NORMAL SALINE. This device is classified as a Diluent, Blood Cell (Class I - General Controls, product code GIF).
Submitted by Cryosan, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1981, 30 days after receiving the submission on August 17, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.8200.
| 510(k) Number | K812309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1981 |
| Decision Date | September 16, 1981 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | GIF — Diluent, Blood Cell |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8200 |