Cleared Traditional

K861812 - HUMAN SERUM - STERILE FILTERED

K861812 is the FDA 510(k) clearance for HUMAN SERUM - STERILE FILTERED by Hazleton Research Products, Inc.. It is a Class 1 Pathology device (product code KIS) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K861812 · Hazleton Research Products, Inc. · Pathology device
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May 1986
Decision
11d
Days
Class 1
Risk

K861812 is an FDA 510(k) clearance for the HUMAN SERUM - STERILE FILTERED. Classified as Sera, Animal And Human (product code KIS), Class I - General Controls.

Submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on May 20, 1986 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2800 - the FDA pathology 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 Hazleton Research Products, Inc. devices

Submission Details

510(k) Number K861812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1986
Decision Date May 20, 1986
Days to Decision 11 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 77d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIS Sera, Animal And Human
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2800
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 - KIS Sera, Animal And Human

All 20
Devices cleared under the same product code (KIS) and FDA review panel - the closest regulatory comparables to K861812.
LAMB SERUM - STERILE FILTERED
K861809 · Hazleton Research Products, Inc. · May 1986
CHICKEN SERUM - STERILE FILTERED
K861810 · Hazleton Research Products, Inc. · May 1986
MOUSE SERUM - STERILE FILTERED
K861811 · Hazleton Research Products, Inc. · May 1986
HUMAN AB SERUM - STERILE FILTERED
K861813 · Hazleton Research Products, Inc. · May 1986
RHESUS MONKEY SERUM - STERILE FILTERED
K861814 · Hazleton Research Products, Inc. · May 1986
BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE
K861815 · Hazleton Research Products, Inc. · May 1986