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FDA 510(k)

LATEX-R RICKETTSII

K-Number: K843794 · 1985-01-04

ApplicantHealth Research, Inc.
Decision Date1985-01-04
Product CodeGPP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LATEX-R RICKETTSII is the device name listed in this FDA 510(k) record. The listed applicant is Health Research, Inc.. It received FDA 510(k) clearance on 1985-01-04 under 510(k) number K843794. The device is classified under product code GPP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX-R RICKETTSII?

LATEX-R RICKETTSII is a medical device that received FDA 510(k) clearance on 1985-01-04. The listed applicant is Health Research, Inc.. The 510(k) number is K843794.

When did LATEX-R RICKETTSII receive FDA 510(k) clearance?

LATEX-R RICKETTSII received FDA 510(k) clearance on 1985-01-04, under 510(k) number K843794.

Who is the listed applicant for LATEX-R RICKETTSII?

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

What is the FDA product code for LATEX-R RICKETTSII?

The FDA product code for LATEX-R RICKETTSII is GPP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Health Research, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K872129LATEX R. CONORIIK860557LATEX R. TYPHI

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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