Cleared Traditional

K060083 - NRBC-CHEX FOR LH

K060083 is an FDA 510(k) clearance for NRBC-CHEX FOR LH, manufactured by Streck. The device is a Class 2 Hematology device with product code GJR cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K060083 · Streck · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
29d
Days
Class 2
Risk

K060083 is an FDA 510(k) clearance for the NRBC-CHEX FOR LH. Classified as Control, Red-cell (product code GJR), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on February 9, 2006 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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FDA 510(k) Submission Details - K060083

510(k) Number K060083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2006
Decision Date February 09, 2006
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJR Device Classification - Class 2, Special Controls

Product Code GJR Control, Red-cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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.