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FDA 510(k)

BENZODIAZEPINE ENZYME IMMUNOASSAY

K-Number: K032365 · 2003-09-05

ApplicantLin-Zhi International, Inc.
Decision Date2003-09-05
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BENZODIAZEPINE 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 2003-09-05 under 510(k) number K032365. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENZODIAZEPINE ENZYME IMMUNOASSAY?

BENZODIAZEPINE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2003-09-05. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K032365.

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

BENZODIAZEPINE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2003-09-05, under 510(k) number K032365.

Who is the listed applicant for BENZODIAZEPINE 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 BENZODIAZEPINE ENZYME IMMUNOASSAY?

The FDA product code for BENZODIAZEPINE ENZYME IMMUNOASSAY is JXM.

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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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