Cleared Traditional

K893975 - DOUBLE ANTIBODY GLUCAGON

K893975 is an FDA 510(k) clearance for DOUBLE ANTIBODY GLUCAGON, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code JME cleared through the Traditional 510(k) pathway after a 151-day FDA review.

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

FDA 510(k) Submission Details - K893975

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.

JME Device Classification - Class 1, General Controls

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.