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FDA 510(k)

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

K-Number: K190397 · 2019-11-15

ApplicantImmunalysis Corporation
Decision Date2019-11-15
Product CodeQBK
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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.

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