K871283 is an FDA 510(k) clearance for the CYANMETHEMOGLOBIN STANDARD. This device is classified as a Calibrator For Hemoglobin And Hematocrit Measurement (Class II - Special Controls, product code KRZ).
Submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on April 15, 1987, 15 days after receiving the submission on March 31, 1987.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8165.
| 510(k) Number | K871283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1987 |
| Decision Date | April 15, 1987 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KRZ — Calibrator For Hemoglobin And Hematocrit Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8165 |