Cleared Traditional

K823929 - MULTIANALYTE CONTROLS-ALL KINDS

K823929 is the FDA 510(k) clearance for MULTIANALYTE CONTROLS-ALL KINDS by Fisher Scientific Co., LLC. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K823929 · Fisher Scientific Co., LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
30d
Days
Class 1
Risk

K823929 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 January 28, 1983 after a review of 30 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 K823929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1982
Decision Date January 28, 1983
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 K823929.
VENTREZYME EIA CONTROLS-IMMUNOASSAY
K833423 · Ventrex Laboratories, Inc. · Dec 1983
ELECTROPHORESIS CONTROLS-3 IN 1
K831263 · Corning Medical & Scientific · Jul 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
K823352 · American Dade · Feb 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490 · Ortho Diagnostic Systems, Inc. · Jan 1983
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850 · American Dade · Oct 1982
TITAN GEL SERUM CONTROL
K821982 · Helena Laboratories · Aug 1982