Cleared Traditional

K935013 - DSL ESTRONE (DSL 8700)

K935013 is an FDA 510(k) clearance for DSL ESTRONE (DSL 8700), manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CGF cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K935013 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Jun 1994
Decision
239d
Days
Class 1
Risk

K935013 is an FDA 510(k) clearance for the DSL ESTRONE (DSL 8700). Classified as Radioimmunoassay, Estrone (product code CGF), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on June 16, 1994 after a review of 239 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1280 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K935013

510(k) Number K935013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date June 16, 1994
Days to Decision 239 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 88d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

CGF Device Classification - Class 1, General Controls

Product Code CGF Radioimmunoassay, Estrone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1280
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.