Cleared Traditional

K830911 - RADIAL IMMUNODIFFUSION PLATES

K830911 is the FDA 510(k) clearance for RADIAL IMMUNODIFFUSION PLATES by Biocell Laboratories, Inc.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K830911 · Biocell Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
81d
Days
Class 2
Risk

K830911 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION PLATES. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Biocell Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 10, 1983 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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 Biocell Laboratories, Inc. devices

Submission Details

510(k) Number K830911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date June 10, 1983
Days to Decision 81 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 104d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 39
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K830911.
TINA-QUANT [A] TRANSFERRIN
K871896 · Boehringer Mannheim Corp. · Jun 1987
PRECIMAT(R) TRANSFERRIN
K871022 · Boehringer Mannheim Corp. · May 1987
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · Abbott Laboratories · Feb 1986
IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN
K812492 · Dako Corp. · Sep 1981
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
K811613 · Kent Laboratories, Inc. · Aug 1981
J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
K801434 · J.T. Baker Chemical Co. · Jul 1980