K Number
K963911Device Name
ALPCO/MERCODIA INSULIN ELISAManufacturer
Date Cleared
1996-11-01
(32 days)
Product Code
Regulation Number
862.1405Type
TraditionalPanel
CHReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 862.1405 Immunoreactive insulin test system.
(a)
Identification. An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.