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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 a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2019-11-15 under approval 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. It is manufactured by Immunalysis Corporation. The 510(k) number is K190397.

When was Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA approved by the FDA?

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

What company makes Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA?

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is manufactured by Immunalysis Corporation.

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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