Cleared Traditional

K834149 - AUTOGROUPER 16C SYS AUTOMATED REAG

K834149 is an FDA 510(k) clearance for AUTOGROUPER 16C SYS AUTOMATED REAG, manufactured by Technicon Instruments Corp.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K834149 · Technicon Instruments Corp. · Microbiology device
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Mar 1984
Decision
99d
Days
Class 2
Risk

K834149 is an FDA 510(k) clearance for the AUTOGROUPER 16C SYS AUTOMATED REAG. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1984 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 866.3820 - 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K834149

510(k) Number K834149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date March 09, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMQ Device Classification - Class 2, Special Controls

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GMQ Antigens, Nontreponemal, All

All 21
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K834149.
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