Class Class II
iDart Lyme IgG ImmunoBlot Kit (K233367)
Description
iDart Lyme IgG ImmunoBlot Kit by Id-Fish Technology, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233367
Clearance Date2024-08-12
Clearance TypeTraditional
Product CodeLSR
Regulation Number866.3830
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233367
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. iDart Lyme IgG ImmunoBlot Kit (K233367) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220016 | Viramed Borrela All-In-One ViraChip Test Kit | Viramed Biotech AG | 2022 |
Trace the full predicate network for K233367
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.