Cleared Traditional

K864137 - LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III

K864137 is an FDA 510(k) clearance for LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I, manufactured by Bio-Rad. The device is a Class 1 Immunology device with product code KIJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K864137 · Bio-Rad · Immunology device
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Nov 1986
Decision
17d
Days
Class 1
Risk

K864137 is an FDA 510(k) clearance for the LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Bio-Rad (Richmond, US). The FDA issued a Cleared decision on November 7, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 878.4820 - the FDA immunology 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 Bio-Rad devices

FDA 510(k) Submission Details - K864137

510(k) Number K864137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date November 07, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 105d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

KIJ Device Classification - Class 1, General Controls

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

All 16
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K864137.
R AND D BATTERY REPLACEMENT
K933337 · R & D Batteries, Inc. · Apr 1994
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K932307 · 3M Health Care, Ltd. · Jan 1994
MODIFIED SAW BLADES TO THE SAGITAL SAW
K884839 · Dyonics, Inc. · Dec 1988
FLUTED SUCTION MENISCAL CUTTER
K850789 · T. Korossurgical Instruments Corp. · Jun 1985
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K822790 · Xomed, Inc. · Oct 1982
INTRA-ARTICULAR SURGICAL SYSTEM
K820367 · Dyonics, Inc. · May 1982