K930070 is an FDA 510(k) clearance for the HEMOCARD HEMOGLOBIN E. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I - General Controls, product code CKA).
Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on April 8, 1993, 92 days after receiving the submission on January 6, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K930070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1993 |
| Decision Date | April 08, 1993 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | CKA — Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1030 |