Cleared Traditional

K894780 - IMMUNO/ASO

K894780 is the FDA 510(k) clearance for IMMUNO/ASO by Immunostics Co., Inc.. It is a Class 1 Microbiology device (product code GTQ) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K894780 · Immunostics Co., Inc. · Microbiology device
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Oct 1989
Decision
81d
Days
Class 1
Risk

K894780 is an FDA 510(k) clearance for the IMMUNO/ASO. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - 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: 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 Immunostics Co., Inc. devices

Submission Details

510(k) Number K894780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date October 16, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 102d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 19
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K894780.
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