Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
K-Number: K143470 · 2016-01-31
Device Summary
Frequently Asked Questions
What is the Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is a medical device that received FDA 510(k) clearance on 2016-01-31. The listed applicant is Diazyme Laboratories. The 510(k) number is K143470.
When did Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set receive FDA 510(k) clearance?
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set received FDA 510(k) clearance on 2016-01-31, under 510(k) number K143470.
Who is the listed applicant for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?
The FDA 510(k) record lists Diazyme Laboratories as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?
The FDA product code for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is GIS.
Other records listing Diazyme Laboratories as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.