Cleared Traditional

K850682 - 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

K850682 is an FDA 510(k) clearance for 72 DETERM. SIZE RADIAL IMMUNO. TEST HUM..., manufactured by Kent Laboratories, Inc.. The device is a Class 2 Immunology device with product code DDB cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K850682 · Kent Laboratories, Inc. · Immunology device
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Nov 1985
Decision
277d
Days
Class 2
Risk

K850682 is an FDA 510(k) clearance for the 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 25, 1985 after a review of 277 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5210 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kent Laboratories, Inc. devices

FDA 510(k) Submission Details - K850682

510(k) Number K850682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1985
Decision Date November 25, 1985
Days to Decision 277 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
172d slower than avg
Panel avg: 105d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDB Device Classification - Class 2, Special Controls

Product Code DDB Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5210
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 - DDB Ceruloplasmin, Antigen, Antiserum, Control

All 18
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K850682.
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K860138 · Sigma Diagnostics, Inc. · Mar 1986
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K852247 · Behring Diagnostics, Inc. · Jul 1985
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K851283 · Cooper Biomedical, Inc. · May 1985
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K823107 · Kallestad Laboratories, Inc. · Nov 1982