Cleared Traditional

K823939 - WAKO INSULIN TEST

K823939 is an FDA 510(k) clearance for WAKO INSULIN TEST, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code CFP cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K823939 · Wako Chemicals USA, Inc. · Chemistry device
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Jan 1983
Decision
30d
Days
Class 1
Risk

K823939 is an FDA 510(k) clearance for the WAKO INSULIN TEST. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (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 862.1405 - 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K823939

510(k) Number K823939 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.

CFP Device Classification - Class 1, General Controls

Product Code CFP Radioimmunoassay, Immunoreactive Insulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1405
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 - CFP Radioimmunoassay, Immunoreactive Insulin

All 20
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K823939.
REP(TM) SPE PLUS-30 PROCEDURES
K896572 · Helena Laboratories · Jan 1990
PHARMACIA INSULIN RIA
K851071 · Pharmacia, Inc. · Apr 1985
INSULIN RADIOIMMUNOASSAY KIT
K841573 · Sorin Biomedica, Fiat, USA, Inc. · May 1984
COVALENT COAT RIA KIT
K822509 · Immuchem Corp. · Sep 1982
COAT-A-COUNT INSULIN KIT
K821861 · Diagnostic Products Corp. · Jul 1982
ENZYMUNE-TEST INSULIN
K821374 · Icl Scientific · May 1982