Cleared Traditional

K033471 - PHOSPHOLIN ES AND CALCIUM CHLORIDE

K033471 is an FDA 510(k) clearance for PHOSPHOLIN ES AND CALCIUM CHLORIDE, manufactured by R2 Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GGW cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K033471 · R2 Diagnostics, Inc. · Hematology device
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Feb 2004
Decision
93d
Days
Class 2
Risk

K033471 is an FDA 510(k) clearance for the PHOSPHOLIN ES AND CALCIUM CHLORIDE. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on February 4, 2004 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all R2 Diagnostics, Inc. devices

FDA 510(k) Submission Details - K033471

510(k) Number K033471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2003
Decision Date February 04, 2004
Days to Decision 93 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 113d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGW Device Classification - Class 2, Special Controls

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 Hematology devices follow this clearance model.

Regulatory Peers - GGW Test, Time, Partial Thromboplastin

All 27
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