Cleared Traditional

K811182 - MULTIANALYTE CONTROLS

K811182 is the FDA 510(k) clearance for MULTIANALYTE CONTROLS by Fisher Scientific Co., LLC. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811182 · Fisher Scientific Co., LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1981
Decision
17d
Days
Class 1
Risk

K811182 is an FDA 510(k) clearance for the MULTIANALYTE CONTROLS, ALL KINDS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K811182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date May 15, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K811182.
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465 · Ortho Diagnostic Systems, Inc. · Jun 1981
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
K811466 · Ortho Diagnostic Systems, Inc. · Jun 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467 · Ortho Diagnostic Systems, Inc. · Jun 1981
CORNING VITAMIN B12 FOLATE DEFIC. CONTR.
K810952 · Corning Medical & Scientific · Apr 1981
TRI-LEVEL RADIOASSAY CONTROL SERA
K803098 · American Diagnostic Corp. · Jan 1981
KEMTROL SERUM CONTROL-NORMAL
K802108 · Helena Laboratories · Oct 1980