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FDA 510(k)

LATEX AGGLUTINATION TEST

K-Number: K851132 · 1985-07-05

ApplicantNew Horizons Diagnostics Co.
Decision Date1985-07-05
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LATEX AGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is New Horizons Diagnostics Co.. It received FDA 510(k) clearance on 1985-07-05 under 510(k) number K851132. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX AGGLUTINATION TEST?

LATEX AGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 1985-07-05. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K851132.

When did LATEX AGGLUTINATION TEST receive FDA 510(k) clearance?

LATEX AGGLUTINATION TEST received FDA 510(k) clearance on 1985-07-05, under 510(k) number K851132.

Who is the listed applicant for LATEX AGGLUTINATION TEST?

The FDA 510(k) record lists New Horizons Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX AGGLUTINATION TEST?

The FDA product code for LATEX AGGLUTINATION TEST is GTZ.

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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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