FIBRINOGEN ASSAY KIT— 510(k) K896052

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K896052 for FIBRINOGEN ASSAY KIT, Substantially Equivalent on 1989-11-09. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Medical Diagnostic Technologies, Inc.
Product code
Product code KQJ
Device class
Class 2
Regulation
21 CFR 864.7340
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ventura, CA, US
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