Cleared Traditional

K882728 - AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190

K882728 is an FDA 510(k) clearance for AMERLITE ENDOCRINOLOGY CONTROL SERA LAN..., manufactured by Amersham Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K882728 · Amersham Corp. · Chemistry device
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Oct 1988
Decision
97d
Days
Class 1
Risk

K882728 is an FDA 510(k) clearance for the AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Amersham Corp. devices

FDA 510(k) Submission Details - K882728

510(k) Number K882728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1988
Decision Date October 06, 1988
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 599
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K882728.
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
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K883124 · Amersham Corp. · Sep 1988
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K882727 · Amersham Corp. · Aug 1988