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FDA 510(k)

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT

K-Number: K903993 · 1990-12-20

ApplicantImmunotech Corp.
Decision Date1990-12-20
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1990-12-20 under 510(k) number K903993. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT?

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT is a medical device that received FDA 510(k) clearance on 1990-12-20. The listed applicant is Immunotech Corp.. The 510(k) number is K903993.

When did MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT receive FDA 510(k) clearance?

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT received FDA 510(k) clearance on 1990-12-20, under 510(k) number K903993.

Who is the listed applicant for MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT?

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(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT?

The FDA product code for MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT is DKZ.

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Other records listing Immunotech Corp. as applicant

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Related Devices (Code: DKZ)

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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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