Cleared Traditional

K872079 - RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS

K872079 is the FDA 510(k) clearance for RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS by Reagents Applications, Inc.. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K872079 · Reagents Applications, Inc. · Immunology device
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Jun 1987
Decision
17d
Days
Class 1
Risk

K872079 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on June 15, 1987 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K872079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1987
Decision Date June 15, 1987
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
87d faster than avg
Panel avg: 104d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - MSJ Apolipoproteins

All 30
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K872079.
APOLIPOPROTEIN A1
K873863 · Unipath , Ltd. · Oct 1987
APOLIPOPROTEIN B
K873864 · Unipath , Ltd. · Oct 1987
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
K872794 · Medix Biotech, Inc. · Sep 1987
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
K862019 · Beckman Instruments, Inc. · Jul 1986
ICS APOLIPOPROTEIN B REAGENT TEST KIT
K862386 · Beckman Instruments, Inc. · Jul 1986
VENTREX APO B
K861919 · Ventrex Laboratories, Inc. · Jun 1986