K780962 is an FDA 510(k) clearance for the AUTOMATED ENZYME. This device is classified as a Solution, Stabilized Enzyme (Class II - Special Controls, product code KSK).
Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978, 45 days after receiving the submission on June 12, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9400.
| 510(k) Number | K780962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1978 |
| Decision Date | July 27, 1978 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSK — Solution, Stabilized Enzyme |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9400 |