Cleared Traditional

K843302 - NEW ALLERG. COATED MICROFILTER WELL STRI

K843302 is the FDA 510(k) clearance for NEW ALLERG. COATED MICROFILTER WELL STRI by Diagnostic Reagent Tech.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K843302 · Diagnostic Reagent Tech. · Immunology device
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Oct 1984
Decision
42d
Days
Class 2
Risk

K843302 is an FDA 510(k) clearance for the NEW ALLERG. COATED MICROFILTER WELL STRI. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Diagnostic Reagent Tech. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 Diagnostic Reagent Tech. devices

Submission Details

510(k) Number K843302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1984
Decision Date October 04, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 104d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 Immunology devices follow this clearance model.

Regulatory Peers - DHB System, Test, Radioallergosorbent (rast) Immunological

All 215
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K843302.
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263 · Pharmacia, Inc. · Jun 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273 · Pharmacia, Inc. · May 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
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PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457 · Pharmacia, Inc. · Jul 1984
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · Ventrex Laboratories, Inc. · May 1984
PHADEBAS RAST PHADEZYM MIX ALLERG
K840670 · Pharmacia, Inc. · Apr 1984