IM-CHECK— 510(k) K834345

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K834345 for IM-CHECK, Substantially Equivalent on 1984-02-10. Applicant: Diagnostic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1983-12-12
Decision date: 1984-02-10
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 Diagnostic Technology, Inc.

K896378 — LYME-CHECK(TM) TEST KIT1991-11-05
K903612 — EBV/EA-CHECK TM TEST KIT1990-10-16
K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT1989-06-20
K890819 — HSV-CHECK(TM) TEST KIT1989-06-20
K891542 — EBNA-CHECK(TM) TEST KIT1989-06-20

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