Class I Immunology device.
K830134 is an FDA 510(k) clearance for the Q-CHECK REAGENT STANDARDS. Classified as Quality Control Slides (product code LJG), Class I - General Controls.
Submitted by Lab Ability, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1983.
This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2660 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K830134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1983 |
| Decision Date | January 09, 1983 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | LJG Quality Control Slides |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 866.2660 |
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.