Cleared Traditional

K834527 - THROMBO PLUS

K834527 is an FDA 510(k) clearance for THROMBO PLUS, manufactured by W. Sarstedt, Inc.. The device is a Class 1 Hematology device with product code GGK cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K834527 · W. Sarstedt, Inc. · Hematology device
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Jan 1984
Decision
40d
Days
Class 1
Risk

K834527 is an FDA 510(k) clearance for the THROMBO PLUS. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by W. Sarstedt, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 40 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.

FDA 510(k) Submission Details - K834527

510(k) Number K834527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date January 30, 1984
Days to Decision 40 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
73d faster than avg
Panel avg: 113d · This submission: 40d
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 27
Devices cleared under the same product code (GGK) and FDA review panel - the closest regulatory comparables to K834527.
IDL-LYSING REAGENT
K842069 · Interscience Diagnostics, Inc. · Jul 1984
LYSING & HEMOGLOBIN REAGENT
K841800 · Reagent Laboratory, Inc. · May 1984
LYSE-TEC
K840289 · Medilab Corp. · Mar 1984
LYSING & HEMOGLOBIN S-REAGENT J & S
K833444 · Jasins & Sayles Associates, Inc. · Nov 1983
LYSING REAGENT
K832182 · Omega Medical Diagnostics · Aug 1983
LYSIS +
K830186 · Hematology Marketing Assoc. · Feb 1983
K834527 · THROMBO PLUS
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