FDA 510(k)

MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011

K-Number: K914696 · 1991-11-13

Decision Date1991-11-13

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1991-11-13 under 510(k) number K914696. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011?

MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K914696.

When did MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 receive FDA 510(k) clearance?

MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 received FDA 510(k) clearance on 1991-11-13, under 510(k) number K914696.

Who is the listed applicant for MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011?

The FDA 510(k) record lists Medix Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011?

The FDA product code for MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 is JHI.

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Other records listing Medix Biotech, Inc. as applicant

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Related Devices (Code: JHI)

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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.