Cleared Traditional

K883049 - ATS PARA-SET IODINE ALCOHOL SOLUTION

K883049 is an FDA 510(k) clearance for ATS PARA-SET IODINE ALCOHOL SOLUTION, manufactured by Alpha-Tec Systems, Inc.. The device is a Class 1 Pathology device with product code JTS cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K883049 · Alpha-Tec Systems, Inc. · Pathology device
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Aug 1988
Decision
29d
Days
Class 1
Risk

K883049 is an FDA 510(k) clearance for the ATS PARA-SET IODINE ALCOHOL SOLUTION. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on August 17, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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 Alpha-Tec Systems, Inc. devices

FDA 510(k) Submission Details - K883049

510(k) Number K883049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1988
Decision Date August 17, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 77d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

JTS Device Classification - Class 1, General Controls

Product Code JTS Stains, Microbiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - JTS Stains, Microbiologic

All 33
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K883049.
ATS LUGOL'S IODINE SOLUTION
K890020 · Alpha-Tec Systems, Inc. · Feb 1989
SNAP N' STAIN IODINE STAIN
K884069 · Scientific Device Laboratory, Inc. · Oct 1988
METHENO-STAIN KIT
K883052 · Scientific Device Laboratory, Inc. · Aug 1988
ATS CRYPTOSPORIDIUM STAIN SET
K880989 · Alpha-Tec Systems, Inc. · May 1988
SDL TRICHROME STAIN
K881598 · Scientific Device Laboratory, Inc. · May 1988
ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)
K881042 · Alpha-Tec Systems, Inc. · Mar 1988