Cleared Traditional

K953437 - OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT

K953437 is an FDA 510(k) clearance for OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBI..., manufactured by Olympus America, Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K953437 · Olympus America, Inc. · Microbiology device
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Oct 1995
Decision
91d
Days
Class 1
Risk

K953437 is an FDA 510(k) clearance for the OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 91 days - within the typical 510(k) review window.

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: 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 Olympus America, Inc. devices

FDA 510(k) Submission Details - K953437

510(k) Number K953437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1995
Decision Date October 20, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 23
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