Submission Details
| 510(k) Number | K800667 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 26, 1980 |
| Decision Date | April 16, 1980 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
K800667 is an FDA 510(k) clearance for the MONITEMP BLOOD PACK TEMP. MONITOR, a Refrigerator, Freezer, Blood Storage (Class II — Special Controls, product code KSE), submitted by Liquid Crystal Products, Inc. (Walker, US). The FDA issued a Cleared decision on April 16, 1980, 21 days after receiving the submission on March 26, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9700.
| 510(k) Number | K800667 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 26, 1980 |
| Decision Date | April 16, 1980 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSE — Refrigerator, Freezer, Blood Storage |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.9700 |