Cleared Traditional

K843794 - LATEX-R RICKETTSII

K843794 is an FDA 510(k) clearance for LATEX-R RICKETTSII, manufactured by Health Research, Inc.. The device is a Class 1 Microbiology device with product code GPP cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K843794 · Health Research, Inc. · Microbiology device
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Jan 1985
Decision
99d
Days
Class 1
Risk

K843794 is an FDA 510(k) clearance for the LATEX-R RICKETTSII. Classified as Antiserum, Rocky Mountain Spotted Fever (product code GPP), Class I - General Controls.

Submitted by Health Research, Inc. (Albany, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3500 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Health Research, Inc. devices

FDA 510(k) Submission Details - K843794

510(k) Number K843794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date January 04, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

GPP Device Classification - Class 1, General Controls

Product Code GPP Antiserum, Rocky Mountain Spotted Fever
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.