K962864 is an FDA 510(k) clearance for the THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS. This device is classified as a Calibrator For Hemoglobin And Hematocrit Measurement (Class II - Special Controls, product code KRZ).
Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on December 18, 1996, 148 days after receiving the submission on July 23, 1996.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8165.
| 510(k) Number | K962864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1996 |
| Decision Date | December 18, 1996 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KRZ — Calibrator For Hemoglobin And Hematocrit Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8165 |