FDA 510(k)

MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY

K-Number: K860490 · 1986-03-05

Decision Date1986-03-05

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY 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 1986-03-05 under 510(k) number K860490. 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 VISUAL HCG - M HCG ENZYME IMMUNOASSAY?

MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K860490.

When did MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1986-03-05, under 510(k) number K860490.

Who is the listed applicant for MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY?

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 VISUAL HCG - M HCG ENZYME IMMUNOASSAY?

The FDA product code for MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY is JHI.

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Other records listing Medix Biotech, Inc. as applicant

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TST K932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KIT K925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT K924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

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Related Devices (Code: JHI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.