Cleared Traditional

K790029 - FLUID, RHEMOX W LYSING

K790029 is an FDA 510(k) clearance for FLUID, manufactured by Sysmex Corp.. The device is a Class 1 Hematology device with product code GGK cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K790029 · Sysmex Corp. · Hematology device
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Feb 1979
Decision
54d
Days
Class 1
Risk

K790029 is an FDA 510(k) clearance for the FLUID, RHEMOX W LYSING. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Sysmex Corp. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1979 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8540 - 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 Sysmex Corp. devices

FDA 510(k) Submission Details - K790029

510(k) Number K790029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1979
Decision Date February 26, 1979
Days to Decision 54 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
59d faster than avg
Panel avg: 113d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

GGK Device Classification - Class 1, General Controls

Product Code GGK Products, Red-cell Lysing Products
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8540
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 - GGK Products, Red-cell Lysing Products

All 15
Devices cleared under the same product code (GGK) and FDA review panel - the closest regulatory comparables to K790029.
LYSING & HEMOGLOBIN REAGENT
K841800 · Reagent Laboratory, Inc. · May 1984
ELUAID
K812002 · Ortho Diagnostic Systems, Inc. · Oct 1981
SERA-PAK TOTAL PROTEIN REAGENT
K802742 · Miles Laboratories, Inc. · Dec 1980
REAGENT, LYSING AND HEMOGLOBIN
K782098 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1979
HEMOLYSE
K781121 · Electrophoresis Corp. of America · Aug 1978
CYMET-AUTOMATED
K771788 · J.T. Baker Chemical Co. · Oct 1977