Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K-Number: K161714 · 2016-10-14
Device Summary
Frequently Asked Questions
What is the Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Immunalysis Corporation. The 510(k) number is K161714.
When did Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators receive FDA 510(k) clearance?
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161714.
Who is the listed applicant for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?
The FDA 510(k) record lists Immunalysis Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?
The FDA product code for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is DIS.
Other records listing Immunalysis Corporation 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.