Cleared Traditional

K950152 - CHEMMATE(TM) UCHL1 (CD45-RO)

K950152 is an FDA 510(k) clearance for CHEMMATE(TM) UCHL1 (CD45-RO), manufactured by Biotek Solutions, Inc.. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K950152 · Biotek Solutions, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
283d
Days
Class 2
Risk

K950152 is an FDA 510(k) clearance for the CHEMMATE(TM) UCHL1 (CD45-RO). Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Biotek Solutions, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 283 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Biotek Solutions, Inc. devices

FDA 510(k) Submission Details - K950152

510(k) Number K950152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date October 27, 1995
Days to Decision 283 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
178d slower than avg
Panel avg: 105d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFH Device Classification - Class 2, Special Controls

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 56
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K950152.
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