THE GOLDEN QUAD TEST (TOXO)— 510(k) K861122

Name: FDA 510(k) clearance K861122
Creator: U.S. Food and Drug Administration
Published: 1987-02-02

Substantially Equivalent

Microbiological Research Corp.

FDA 510(k) clearance K861122 for THE GOLDEN QUAD TEST (TOXO), Substantially Equivalent on 1987-02-02. Applicant: Microbiological Research Corp.. Device class: 2.

Clearance details

Applicant: Microbiological Research Corp.
Product code: Code LJK
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1986-03-25
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJK

view all

K974261 — ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL1997-12-11
K911771 — ARD(TM) ANTIMICROBIAL REMOVAL DEVICE1991-07-01
K861460 — SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K1011986-05-02
K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT1983-09-26
K822605 — TOXOPLASMA GONDII ANTIBODY IGG1982-10-27

More clearances from Microbiological Research Corp.

view all

K883011 — MRI NEO-TRYP TRYPSIN RIA1989-04-26
K861120 — THE GOLDEN QUAD TEST (HSV)1987-02-02
K861121 — THE GOLDEN QUAD TEST (EBV)1987-02-02
K861123 — THE GOLDEN QUAD TEST (CMV)1987-02-02
K860450 — THE CMV-IGM TEST1986-05-13

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