RUBELLA ANTIBODY FLUOROIMMUNOASSAY— 510(k) K841174

Name: FDA 510(k) clearance K841174
Creator: U.S. Food and Drug Administration
Published: 1984-06-07

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K841174 for RUBELLA ANTIBODY FLUOROIMMUNOASSAY, Substantially Equivalent on 1984-06-07. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code GOL
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1984-03-19
Decision date: 1984-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GOL

view all

K834032 — RUBAQUICK DIAGNOSTIC KIT1984-04-17
K810309 — RUBELLA ANTIBODIES TEST REAGENTS1981-03-11
K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI1980-12-18
K802339 — EIA RUBELLA-G1980-12-18
K802508 — RUBELISA IGM TEST KIT1980-12-18

More clearances from Intl. Diagnostic Technology

view all

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.