K810617 is an FDA 510(k) clearance for the MOBILE MATIC AUTOMATIC DONOR SCALE. This device is classified as a Device, Blood Mixing And Blood Weighing (Class I - General Controls, product code KSQ).
Submitted by Lifeline Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 7, 1981, 29 days after receiving the submission on March 9, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9195.
| 510(k) Number | K810617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1981 |
| Decision Date | April 07, 1981 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSQ — Device, Blood Mixing And Blood Weighing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.9195 |