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FDA 510(k)

RESPIRALEX LATEX AGGLUTINATION TEST

K-Number: K844399 · 1985-01-08

ApplicantOrion Diagnostica, Inc.
Decision Date1985-01-08
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESPIRALEX LATEX AGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K844399. 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 RESPIRALEX LATEX AGGLUTINATION TEST?

RESPIRALEX LATEX AGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K844399.

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

RESPIRALEX LATEX AGGLUTINATION TEST received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844399.

Who is the listed applicant for RESPIRALEX LATEX AGGLUTINATION TEST?

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

What is the FDA product code for RESPIRALEX LATEX AGGLUTINATION TEST?

The FDA product code for RESPIRALEX 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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