FIAX TOXO-M ANTIBODIES TEST KIT— 510(k) K850591

Name: FDA 510(k) clearance K850591
Creator: U.S. Food and Drug Administration
Published: 1985-04-30

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K850591 for FIAX TOXO-M ANTIBODIES TEST KIT, Substantially Equivalent on 1985-04-30. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code GLZ
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1985-02-14
Decision date: 1985-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GLZ

view all

K924882 — TOXOPLASMA IGM IFA TEST SYSTEM1993-03-23
K880007 — TOXO IGM TEST1988-03-17
K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII1985-01-07
K842664 — ANTI-TOXOPLASMA GONDII KIT1984-08-28
K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI1983-11-14

More clearances from Intl. Diagnostic Technology

view all

K843570 — FIAX HAPTOGLOBIN TEST KIT1984-10-05
K843621 — FIAX 420 DILUTOR1984-09-28
K843356 — FIAX 100 FLUOROMETER1984-09-17
K842749 — FIAX TOTAL IGE TEST KIT1984-08-28
K842071 — FIAX TRANSFERRIN TEST KIT1984-07-11

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