CYTOMEGALOVIRUS CONTROL SLIDES— 510(k) K873114

Name: FDA 510(k) clearance K873114
Creator: U.S. Food and Drug Administration
Published: 1987-09-25

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K873114 for CYTOMEGALOVIRUS CONTROL SLIDES, Substantially Equivalent on 1987-09-25. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code GQH
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1987-08-10
Decision date: 1987-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQH

view all

K982311 — BARTELS CINAKIT CMV ANTIGENEMIA1998-12-14
K964875 — CMV ANTIGEN CONTROL SLIDES1997-03-18
K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY1994-05-05
K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV)1988-12-05
K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG1988-08-03

More clearances from Medical Diagnostic Technologies, Inc.

view all

K062229 — CTC WORKSTATION, MODEL 22002006-09-11
K972209 — SPECTROLYSE HEPARIN (ANTI-IIA)1997-08-12
K963106 — CHROMOLIZE PAI-1 KIT1996-11-18
K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA)1996-08-14
K962489 — CHROMOLIZE TPA ASSAY KIT1996-07-31

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