Cleared Traditional

K862173 - PERENNIAL RYE ALLERGEN DISC

K862173 is an FDA 510(k) clearance for PERENNIAL RYE ALLERGEN DISC, manufactured by Immuno Nuclear Corp.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K862173 · Immuno Nuclear Corp. · Immunology device
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Jul 1986
Decision
24d
Days
Class 2
Risk

K862173 is an FDA 510(k) clearance for the PERENNIAL RYE ALLERGEN DISC. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Immuno Nuclear Corp. (Stillwater, US). The FDA issued a Cleared decision on July 3, 1986 after a review of 24 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 Immuno Nuclear Corp. devices

FDA 510(k) Submission Details - K862173

510(k) Number K862173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1986
Decision Date July 03, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 105d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K862173.
COTTONWOOD ALLERGEN DISC
K862265 · Immuno Nuclear Corp. · Aug 1986
JUNE GRASS ALLERGEN DISC
K862938 · Immuno Nuclear Corp. · Aug 1986
ORCHARD GRASS ALLERGEN DISC
K862939 · Immuno Nuclear Corp. · Aug 1986
ENGLISH PLAINTAIN ALLERGEN DISC
K862264 · Immuno Nuclear Corp. · Jul 1986
WHITE OAK ALLERGEN DISC
K862175 · Immuno Nuclear Corp. · Jun 1986
SHORT RAGWEED ALLERGEN DISC
K854756 · Immuno Nuclear Corp. · May 1986