Cleared Traditional

K830096 - PHADEBAS & PHADEZYME RAST ALLERGEN DISC

K830096 is the FDA 510(k) clearance for PHADEBAS & PHADEZYME RAST ALLERGEN DISC by Pharmacia, Inc.. It is a Class 2 Chemistry device (product code DHB) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K830096 · Pharmacia, Inc. · Chemistry device
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Jan 1983
Decision
17d
Days
Class 2
Risk

K830096 is an FDA 510(k) clearance for the PHADEBAS & PHADEZYME RAST ALLERGEN DISC. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5750 - 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K830096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date January 28, 1983
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
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 Chemistry devices follow this clearance model.

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

All 187
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K830096.
PHADEBAS & PHADEZYM RAST TEST ALLERG
K823592 · Pharmacia, Inc. · Mar 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K830155 · Pharmacia, Inc. · Mar 1983
RIASSIST RAST DATA REDUCTION/QUALITY
K830170 · Ventrex Laboratories, Inc. · Feb 1983
ALLERCOAT ALLERGEN DISCS
K823470 · Kallestad Laboratories, Inc. · Dec 1982
PHADEBAS RAST TEST
K822141 · Pharmacia, Inc. · Aug 1982
VAST VENTREX ALLERGY SYSTEMS TESTS
K821451 · Ventrex Laboratories, Inc. · Jun 1982