FIAX TOTAL IGE TEST KIT— 510(k) K842749

Name: FDA 510(k) clearance K842749
Creator: U.S. Food and Drug Administration
Published: 1984-08-28

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K842749 for FIAX TOTAL IGE TEST KIT, Substantially Equivalent on 1984-08-28. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DGP
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1984-07-13
Decision date: 1984-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DGP

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K931224 — VIDAS TOTAL IGE (IGE) ASSAY1993-05-20
K863327 — IMMPULSE IGE ASSAY REAGENTS1986-12-03
K842969 — ALLERGENETICS ALLER-SPECIFIC IGE SERUM1984-08-28

More clearances from Intl. Diagnostic Technology

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K850591 — FIAX TOXO-M ANTIBODIES TEST KIT1985-04-30
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K843621 — FIAX 420 DILUTOR1984-09-28
K843356 — FIAX 100 FLUOROMETER1984-09-17
K842071 — FIAX TRANSFERRIN TEST KIT1984-07-11

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