AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS— 510(k) K791455

Name: FDA 510(k) clearance K791455
Creator: U.S. Food and Drug Administration
Published: 1979-12-31

Substantially Equivalent

Volu Sol Medical Industries

FDA 510(k) clearance K791455 for AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS, Substantially Equivalent on 1979-12-31. Applicant: Volu Sol Medical Industries. Device class: 2.

Clearance details

Applicant: Volu Sol Medical Industries
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1979-08-06
Decision date: 1979-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTN

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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 Volu Sol Medical Industries

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K822126 — VOLU-SOL CARNOY FLUID1982-08-05
K822127 — VOLU-SOL ZENKERS FIXATIVE1982-08-05
K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN1982-08-05
K822129 — VOLU-SOL BOVINS FIXATIVE1982-08-05
K822035 — VOLU-SOL GILLS EA1982-08-03

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