Cleared Traditional

K030546 - CRP (II) CALIBRATORS

K030546 is the FDA 510(k) clearance for CRP (II) CALIBRATORS by Denka Seiken Co., Ltd.. It is a Class 2 Immunology device (product code JIS) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K030546 · Denka Seiken Co., Ltd. · Immunology device
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Jun 2003
Decision
102d
Days
Class 2
Risk

K030546 is an FDA 510(k) clearance for the CRP (II) CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Denka Seiken Co., Ltd. (Gosen City, Niigata, JP). The FDA issued a Cleared decision on June 2, 2003 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Denka Seiken Co., Ltd. devices

Submission Details

510(k) Number K030546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date June 02, 2003
Days to Decision 102 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 104d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 94
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