TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560— 510(k) K860773

Name: FDA 510(k) clearance K860773
Creator: U.S. Food and Drug Administration
Published: 1986-05-23

Substantially Equivalent

Clinical Sciences, Inc.

FDA 510(k) clearance K860773 for TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560, Substantially Equivalent on 1986-05-23. Applicant: Clinical Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Sciences, Inc.
Product code: Product code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1986-03-03
Decision date: 1986-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGD

view all

K242022 — Access Toxo IgG2025-03-28
K242095 — Access Toxo IgM II2024-10-11
K233932 — Alinity i Toxo IgM2024-08-30
K210596 — ARCHITECT Toxo IgG2022-05-19
K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl2017-06-23

More clearances from Clinical Sciences, Inc.

view all

K900688 — VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT1990-05-15
K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #45901989-07-14
K883871 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #55901989-07-14
K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #46001989-06-15
K883600 — EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #45501989-05-11

Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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