Cleared Traditional

K853261 - LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)

K853261 is an FDA 510(k) clearance for LASER RBP LASER(RETINOL BINDING PROTEIN..., manufactured by Behring Diagnostics, Inc.. The device is a Class 1 Immunology device with product code CZS cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K853261 · Behring Diagnostics, Inc. · Immunology device
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Aug 1985
Decision
20d
Days
Class 1
Risk

K853261 is an FDA 510(k) clearance for the LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS). Classified as Retinol-binding Protein, Antigen, Antiserum, Control (product code CZS), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5765 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K853261

510(k) Number K853261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1985
Decision Date August 22, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 105d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

CZS Device Classification - Class 1, General Controls

Product Code CZS Retinol-binding Protein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5765
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.