K822812 is an FDA 510(k) clearance for the YSI MODEL 23L LACTATE ANALYZER. This device is classified as a Table, Obstetrical, Manual (and Accessories) (Class II - Special Controls, product code HHP).
Submitted by Yellow Springs Instrument Co., Inc. (Walker, US). The FDA issued a Cleared decision on December 13, 1982, 84 days after receiving the submission on September 20, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 884.4900.
| 510(k) Number | K822812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1982 |
| Decision Date | December 13, 1982 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | HHP — Table, Obstetrical, Manual (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4900 |