MONO-TEC— 510(k) K841863

Substantially Equivalent

Medilab Corp.

FDA 510(k) clearance K841863 for MONO-TEC, Substantially Equivalent on 1984-06-13. Applicant: Medilab Corp.. Device class: 2.

Clearance details

Applicant: Medilab Corp.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1984-05-04
Decision date: 1984-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTN

K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test2018-06-22
K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)2005-02-28
K030215 — BIORAPID MONONUCLEOSIS2003-02-24
K012901 — COLOR-MONOGEN2001-09-27
K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT1999-01-28

More clearances from Medilab Corp.

K841862 — IMMU-TEC1984-06-13
K840290 — MCS TOTAL PROTEIN REAGENT1984-03-30
K840291 — MCS ALBUMIN REAGENT1984-03-30
K840289 — LYSE-TEC1984-03-05
K832918 — PREGNA-TEC1983-11-03

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