Cleared Traditional

K791650 - HUMAN

K791650 is an FDA 510(k) clearance for HUMAN, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K791650 · Beckman Instruments, Inc. · Immunology device
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Sep 1979
Decision
27d
Days
Class 2
Risk

K791650 is an FDA 510(k) clearance for the HUMAN, C-REACTIVE PROTEIN (CRP). Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 27 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K791650

510(k) Number K791650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date September 17, 1979
Days to Decision 27 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
77d faster than avg
Panel avg: 104d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K791650.
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984 · Kallestad Laboratories, Inc. · Jul 1982
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
K811617 · Kallestad Laboratories, Inc. · Jun 1981
AGGLUTINOTEST-C-REACTIVE PROTEIN
K791461 · Volu Sol Medical Industries · Dec 1979
TEST, SLIDE FOR C-REATIVE PROTEIN
K760354 · Icl Scientific · Aug 1976