Cleared Traditional

K920001 - HEMOLAB SILIMAT REAGENT

K920001 is an FDA 510(k) clearance for HEMOLAB SILIMAT REAGENT, manufactured by Biomerieux Vitek, Inc.. The device is a Class 1 Hematology device with product code GFI cleared through the Traditional 510(k) pathway after a 267-day FDA review.

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

FDA 510(k) Submission Details - K920001

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 113d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

GFI Device Classification - Class 1, General Controls

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.