Cleared Traditional

K944288 - HEMAGEN C-REACTIVE PROTEIN KIT (EIA MET...

K944288 is the FDA 510(k) clearance for HEMAGEN C-REACTIVE PROTEIN KIT (EIA MET... by Hemagen Diagnostics, Inc.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K944288 · Hemagen Diagnostics, Inc. · Immunology device
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Oct 1994
Decision
31d
Days
Class 2
Risk

K944288 is an FDA 510(k) clearance for the HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD). Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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 Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K944288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1994
Decision Date October 03, 1994
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 104d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
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 Immunology devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 82
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K944288.
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K953197 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212 · Randox Laboratories, Ltd. · Jul 1995
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
K951057 · Medical Analysis Systems, Inc. · Apr 1995
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · Behring Diagnostics, Inc. · Oct 1994
TINA-QUANT CRP
K930621 · Boehringer Mannheim Corp. · Mar 1993
VIGIL II
K920845 · Beckman Instruments, Inc. · Dec 1992