LYME DISEASE IFA (IGG)— 510(k) K883487

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K883487 for LYME DISEASE IFA (IGG), Substantially Equivalent on 1988-12-13. Applicant: Hillcrest Biologicals. Device class: 2.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1988-08-16
Decision date: 1988-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LSR

K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA2026-07-10
K252627 — Lyme-ID IgG Test; Bio-ID8002025-11-14
K242872 — iDart Lyme IgM ImmunoBlot Kit2025-06-12
K233367 — iDart Lyme IgG ImmunoBlot Kit2024-08-12
K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit2023-07-13

More clearances from Hillcrest Biologicals

K913617 — ARBOVIRUS IGG IFA TEST1992-12-03
K913618 — ARBOVIRUS IGM IFA TEST1992-12-03
K913906 — Q FEVER IGG IFA TEST1992-10-21
K922374 — Q FEVER IGM IFA TEST1992-10-21
K900206 — LYME DISEASE IGM ELISA1991-06-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.