TOXOPLASMA GONDII— 510(k) K864981

Substantially Equivalent

Virion (U.S.), Inc.

FDA 510(k) clearance K864981 for TOXOPLASMA GONDII, Substantially Equivalent on 1987-10-30. Applicant: Virion (U.S.), Inc.. Device class: 2.

Clearance details

Applicant: Virion (U.S.), Inc.
Product code: Code GMN
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1986-12-22
Decision date: 1987-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMN

K894261 — TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN1989-10-16
K791456 — AGGLUTINOTEST-TOXOPLASMOSIS1979-09-24

More clearances from Virion (U.S.), Inc.

K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST1994-06-13
K921618 — COXSACKIE VIRUS B1-B6 CF ANTIGENS1992-06-29
K905306 — MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN1991-06-17
K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN1991-03-21

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