Class I Chemistry device.
K770998 is an FDA 510(k) clearance for the CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.
Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1977.
This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K770998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1977 |
| Decision Date | June 02, 1977 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | CHH Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 862.1175 |
Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.