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FDA 510(k)

OPIATE ENZYME IMMUNOASSAY

K-Number: K110298 · 2011-07-15

ApplicantLin-Zhi International, Inc.
Decision Date2011-07-15
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPIATE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2011-07-15 under 510(k) number K110298. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPIATE ENZYME IMMUNOASSAY?

OPIATE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2011-07-15. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K110298.

When did OPIATE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

OPIATE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2011-07-15, under 510(k) number K110298.

Who is the listed applicant for OPIATE ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPIATE ENZYME IMMUNOASSAY?

The FDA product code for OPIATE ENZYME IMMUNOASSAY is DJG.

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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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