Cleared Traditional

HEMOLAB SILIMAT REAGENT (K920001) - FDA 510(k) Clearance

Class I Hematology device.

K920001 · Biomerieux Vitek, Inc. · Hematology device
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Sep 1992
Decision
267d
Days
Class 1
Risk

K920001 is an FDA 510(k) clearance for the HEMOLAB SILIMAT REAGENT. Classified as Osteotome, Manual (product code GFI), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 25, 1992 after a review of 267 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 878.4800 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K920001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date September 25, 1992
Days to Decision 267 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 113d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GFI Osteotome, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.