Cleared Abbreviated

AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER (K062932) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K062932 · Ahlstrom Mount Holly Springs, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
386d
Days
Class 2
Risk

K062932 is an FDA 510(k) clearance for the AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Ahlstrom Mount Holly Springs, LLC (Mount Holly Springs, US). The FDA issued a Cleared decision on October 19, 2007 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ahlstrom Mount Holly Springs, LLC devices

Submission Details

510(k) Number K062932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date October 19, 2007
Days to Decision 386 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
298d slower than avg
Panel avg: 88d · This submission: 386d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 236
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