Cleared Traditional

K812004 - GASTRIN RIA DIAGNOSTIC KIT

K812004 is an FDA 510(k) clearance for GASTRIN RIA DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CGC cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812004 · Abbott Laboratories · Chemistry device
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Jul 1981
Decision
14d
Days
Class 1
Risk

K812004 is an FDA 510(k) clearance for the GASTRIN RIA DIAGNOSTIC KIT. Classified as Radioimmunoassay, Gastrin (product code CGC), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1325 - 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K812004

510(k) Number K812004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1981
Decision Date July 28, 1981
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

CGC Device Classification - Class 1, General Controls

Product Code CGC Radioimmunoassay, Gastrin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1325
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.

Regulatory Peers - CGC Radioimmunoassay, Gastrin

Devices cleared under the same product code (CGC) and FDA review panel - the closest regulatory comparables to K812004.
DPC GASTRIN KIT
K833489 · Diagnostic Products Corp. · Jan 1984
GASTRIN RADIOIMMUNOASSAY KIT (125-I)
K821175 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT
K812727 · Immuno Nuclear Corp. · Nov 1981
GASTRIN RADIOIMMUNOASSAY TEST
K810722 · Clinical Assays, Inc. · May 1981