Cleared Traditional

K830203 - DAC-CEL DIAGNATAL RD 50

K830203 is the FDA 510(k) clearance for DAC-CEL DIAGNATAL RD 50 by Wellcome Diagnostics. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K830203 · Wellcome Diagnostics · Chemistry device
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Feb 1983
Decision
29d
Days
Class 2
Risk

K830203 is an FDA 510(k) clearance for the DAC-CEL DIAGNATAL RD 50. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Wellcome Diagnostics (Walker, US). The FDA issued a Cleared decision on February 18, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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.

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Submission Details

510(k) Number K830203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1983
Decision Date February 18, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K830203.
ARIA II I-HCG
K830997 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1983
DUOCLON SLIDE TEST
K831109 · Organon, Inc. · Jun 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1983
TANDEM E GCG VISUAL END POINT INNUMOENZ
K830138 · Hybritech, Inc. · Feb 1983
GENESIS B-HCG
K823753 · Armkel, LLC · Jan 1983
B-HCG
K822343 · Diagnostic Products Corp. · Sep 1982