Cleared Traditional

K983356 - C4

K983356 is an FDA 510(k) clearance for C4, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K983356 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
41d
Days
Class 2
Risk

K983356 is an FDA 510(k) clearance for the C4. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K983356

510(k) Number K983356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1998
Decision Date November 04, 1998
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

Product Code DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 26
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K983356.
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · Dade Behring, Inc. · Mar 2000
C4 MININEPH ANTISERUM
K981785 · The Binding Site, Ltd. · Dec 1999
K-ASSAY C4
K993481 · Kamiya Biomedical Co. · Nov 1999
N-ASSAY TIA C4 TEST KIT
K964297 · Crestat Diagnostics, Inc. · Jul 1997
N-ASSAY TIA MULTI V-NL
K964300 · Crestat Diagnostics, Inc. · Jul 1997
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · Olympus America, Inc. · Oct 1996