K840105 is an FDA 510(k) clearance for the APO A-I RIA KIT-HUMAN PLASMA APOLIP-.
Submitted by Iso-Tex Diagnostics (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984.
This device falls under the Chemistry FDA review panel. 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 | K840105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | January 10, 1984 |
| Decision Date | January 10, 1984 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | - |
| Device Class | - |
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.