Cleared Traditional

DOUBLE ANTIBODY GLUCAGON (K893975) - FDA 510(k) Clearance

Class I Chemistry device.

K893975 · Diagnostic Products Corp. · Chemistry device
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Oct 1989
Decision
151d
Days
Class 1
Risk

K893975 is an FDA 510(k) clearance for the DOUBLE ANTIBODY GLUCAGON. Classified as Radioimmunoassay, Glucagon (product code JME), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 151 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1335 - 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 Products Corp. devices

Submission Details

510(k) Number K893975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1989
Decision Date October 31, 1989
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 88d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JME Radioimmunoassay, Glucagon
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1335
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.