Cleared Traditional

K830134 - Q-CHECK REAGENT STANDARDS

K830134 is an FDA 510(k) clearance for Q-CHECK REAGENT STANDARDS, manufactured by Lab Ability, Inc.. The device is a Class 1 Immunology device with product code LJG cleared through the Traditional 510(k) pathway .

K830134 · Lab Ability, Inc. · Immunology device
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Jan 1983
Decision
-
Days
Class 1
Risk

K830134 is an FDA 510(k) clearance for the Q-CHECK REAGENT STANDARDS. Classified as Quality Control Slides (product code LJG), Class I - General Controls.

Submitted by Lab Ability, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1983.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2660 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lab Ability, Inc. devices

FDA 510(k) Submission Details - K830134

510(k) Number K830134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1983
Decision Date January 09, 1983
Days to Decision -
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

LJG Device Classification - Class 1, General Controls

Product Code LJG Quality Control Slides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.

Regulatory Peers - LJG Quality Control Slides

All 18
Devices cleared under the same product code (LJG) and FDA review panel - the closest regulatory comparables to K830134.
ACID FAST BACILLI STAIN CONTROL
K840515 · Scientific Device Laboratory, Inc. · Mar 1984
METACHROMATIC GRANULE STAIN CONTROL
K840516 · Scientific Device Laboratory, Inc. · Mar 1984
PROTOZOA STAIN CONTROL
K840517 · Scientific Device Laboratory, Inc. · Mar 1984
ATS GRAM STAIN CONTROL SLIDE
K823704 · Alpha-Tec Systems, Inc. · Jan 1983
ATS PARASITOLOGY STAIN CONTROL SLIDE
K823705 · Alpha-Tec Systems, Inc. · Jan 1983
ATS AFB STAIN CONTROL SLIDE
K823706 · Alpha-Tec Systems, Inc. · Jan 1983