← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LSR — Reagent, Borrelia Serological Reagent

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3830
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K254295Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · 510k2026-07-10
K252627Inanovate, Inc. · 510k2025-11-14
K242872Id-Fish Technology, Inc. · 510k2025-06-12

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →