Cleared Traditional

K834390 - IMMUNO-CRP

K834390 is the FDA 510(k) clearance for IMMUNO-CRP by Immunostics Co., Inc.. It is a Class 2 Microbiology device (product code DCN) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K834390 · Immunostics Co., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
51d
Days
Class 2
Risk

K834390 is an FDA 510(k) clearance for the IMMUNO-CRP. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Immunostics Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5270 - the FDA microbiology 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 Immunostics Co., Inc. devices

Submission Details

510(k) Number K834390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date February 03, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Microbiology devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 38
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K834390.
CPR SLIDE EIKEN
K854819 · Syn-Kit, Inc. · Feb 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · Behring Diagnostics, Inc. · Feb 1986
CRP SLIDE TEST KIT
K840699 · Difco Laboratories, Inc. · Mar 1984
EMIT C-REACTIVE PROTEIN ASSAY
K821413 · Syva Co. · May 1982
IMMUNEX CRP
K812881 · Armkel, LLC · Oct 1981
CRP SLIDE
K810862 · Syn-Kit, Inc. · Apr 1981