FDA 510(k)

Immunalysis卡西普罗代谢物/美普他酮尿液高效液相色谱免疫测定

K号: K190397 · 2019-11-15

决定日期2019-11-15

产品代码QBK

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决定实质等同

器械摘要

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K190397. The device is classified under product code QBK. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA?

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Immunalysis Corporation. The 510(k) number is K190397.

When did Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA receive FDA 510(k) clearance?

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA received FDA 510(k) clearance on 2019-11-15, under 510(k) number K190397.

Who is the listed applicant for Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA?

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 Carisoprodol Metabolite / Meprobamate Urine HEIA?

The FDA product code for Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is QBK.

列明Immunalysis Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

相关临床试验

列明Immunalysis Corporation为申报人的其他记录

官方来源