Cleared Traditional

K852701 - FISHER DIAGNOSTIC LATEST ASO TEST KIT

K852701 is an FDA 510(k) clearance for FISHER DIAGNOSTIC LATEST ASO TEST KIT, manufactured by Allied Fisher Scientific. The device is a Class 1 Immunology device with product code GTQ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K852701 · Allied Fisher Scientific · Immunology device
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Jul 1985
Decision
23d
Days
Class 1
Risk

K852701 is an FDA 510(k) clearance for the FISHER DIAGNOSTIC LATEST ASO TEST KIT. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Allied Fisher Scientific (Orangeburg, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3720 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allied Fisher Scientific devices

FDA 510(k) Submission Details - K852701

510(k) Number K852701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date July 19, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 105d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

GTQ Device Classification - Class 1, General Controls

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
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 - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 24
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K852701.
LASER ASO KIT
K854039 · Behring Diagnostics, Inc. · Oct 1985
V-TREND ASO PLUS LATEX TEST
K853857 · Texas Immunology, Inc. · Oct 1985
ASO SLIDE EIKEN
K853276 · Syn-Kit, Inc. · Aug 1985
SERIMM SURE ASO-CHEK CONTROL SERUM
K842839 · Analytical Products, Inc. · Aug 1984
ASO-CHECK
K831464 · Diagnostic Technology, Inc. · Jun 1983
ASO SURE
K820785 · Analytical Products, Inc. · Apr 1982