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FDA 510(k)

VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS

K-Number: K920856 · 1992-03-26

ApplicantHycor Biomedical, Inc.
Decision Date1992-03-26
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical, Inc.. It received FDA 510(k) clearance on 1992-03-26 under 510(k) number K920856. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS?

VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS is a medical device that received FDA 510(k) clearance on 1992-03-26. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K920856.

When did VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS receive FDA 510(k) clearance?

VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS received FDA 510(k) clearance on 1992-03-26, under 510(k) number K920856.

Who is the listed applicant for VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS?

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

What is the FDA product code for VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS?

The FDA product code for VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS is JLW.

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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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