FIAX IGM TEST KIT— 510(k) K831608

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K831608 for FIAX IGM TEST KIT, Substantially Equivalent on 1983-06-22. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1983-05-18
Decision date: 1983-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DFT

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K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS1994-12-12
K901453 — QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD1990-04-12

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.