FIAX IGG TEST KIT— 510(k) K831609

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K831609 for FIAX IGG TEST KIT, Substantially Equivalent on 1983-06-17. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DGK
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1983-05-18
Decision date: 1983-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code DGK

K831908 — RABBIT ANTISERUM TO HUMAN IGG1983-07-18

More clearances from Intl. Diagnostic Technology

K850591 — FIAX TOXO-M ANTIBODIES TEST KIT1985-04-30
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

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