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FDA 510(k)

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT

K-Number: K911153 · 1991-06-18

ApplicantImmunotech Corp.
Decision Date1991-06-18
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1991-06-18 under 510(k) number K911153. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT?

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT is a medical device that received FDA 510(k) clearance on 1991-06-18. The listed applicant is Immunotech Corp.. The 510(k) number is K911153.

When did MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT receive FDA 510(k) clearance?

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT received FDA 510(k) clearance on 1991-06-18, under 510(k) number K911153.

Who is the listed applicant for MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT?

The FDA 510(k) record lists Immunotech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT?

The FDA product code for MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT is LCM.

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Related Devices (Code: LCM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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