FDA.reportPublic FDA data

510(k) K233367

Device
iDart Lyme IgG ImmunoBlot Kit
Applicant
Id-Fish Technology, Inc.
510(k) number
K233367
Product code
LSR
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-12
Date received
2023-10-02
Regulation
866.3830
Classification name
Reagent, Borrelia Serological Reagent
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jyotsna Shah
Address
556 Gibraltar Dr. Milpitas CA US 95035 95035

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LSR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.2025-11-14
K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.2025-06-12
K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus Scientific2023-07-13
K220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG2022-08-19
K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics2021-03-22
K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics2021-03-22
K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics2021-03-22
K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitGold Standard Diagnostics2021-03-22
K202574LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusDiaSorin, Inc.2021-02-18
K202573LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusDiaSorin, Inc.2021-02-18
K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics2020-04-06
K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics2020-04-06
K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetDiaSorin, Inc.2020-01-29
K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemZeus Scientific, Inc.2019-07-29
K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemZeus Scientific, Inc.2019-07-29