Cleared Traditional

K830578 - MICROHEMATOCRIT READER

K830578 is the FDA 510(k) clearance for MICROHEMATOCRIT READER by Fisher Scientific Co., LLC. It is a Class 2 Hematology device (product code JPI) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K830578 · Fisher Scientific Co., LLC · Hematology device
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Mar 1983
Decision
29d
Days
Class 2
Risk

K830578 is an FDA 510(k) clearance for the MICROHEMATOCRIT READER. Classified as Device, Hematocrit Measuring (product code JPI), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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: 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K830578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date March 24, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPI Device, Hematocrit Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPI Device, Hematocrit Measuring

Devices cleared under the same product code (JPI) and FDA review panel - the closest regulatory comparables to K830578.
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183680 · Abbott Point of Care, Inc. · Feb 2020
i-STAT Hematocrit test with i-STAT Alinity System
K163342 · Abbott Laboratories · Aug 2017
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
K852482 · Em Diagnostic Systems, Inc. · Jul 1985
MICRO-HEMATOCRIT CENTRIFUGE 335/336
K823558 · Fisher Scientific Co., LLC · Jan 1983