Cleared Traditional

K840768 - CENTRIFUGES

K840768 is an FDA 510(k) clearance for CENTRIFUGES, manufactured by Heraeus-Christ GmbH. The device is a Class 1 Hematology device with product code JQC cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K840768 · Heraeus-Christ GmbH · Hematology device
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May 1984
Decision
74d
Days
Class 1
Risk

K840768 is an FDA 510(k) clearance for the CENTRIFUGES. Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Heraeus-Christ GmbH (Walker, US). The FDA issued a Cleared decision on May 7, 1984 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - 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 - K840768

510(k) Number K840768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date May 07, 1984
Days to Decision 74 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
39d faster than avg
Panel avg: 113d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

JQC Device Classification - Class 1, General Controls

Product Code JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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 - JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

All 33
Devices cleared under the same product code (JQC) and FDA review panel - the closest regulatory comparables to K840768.
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.
K843434 · Iso-Data, Inc. · Oct 1984
UNIVERSAL 2 S CENTRIFUGE
K843087 · Boehringer Mannheim Corp. · Aug 1984
EBA 3 S CENTRIFUGE
K843088 · Boehringer Mannheim Corp. · Aug 1984
LKB 2164 MACRO-SPIN R CENTRIFUGE
K831942 · Lkb Instruments, Inc. · Jul 1983
LKB 2160 MIDISPIN CENTRIFUGE
K831947 · Lkb Instruments, Inc. · Jul 1983
LKB 2161 MIDISPIN R CENTRIFUGE
K831948 · Lkb Instruments, Inc. · Jul 1983
K840768 · CENTRIFUGES
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