Cleared Traditional

K883814 - DELFIA HLH SPEC KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K883814 · Pharmacia, Inc. · Chemistry device
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Mar 1989
Decision
181d
Days
Class 1
Risk

K883814 is an FDA 510(k) clearance for the DELFIA HLH SPEC KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on March 8, 1989 after a review of 181 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K883814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1988
Decision Date March 08, 1989
Days to Decision 181 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 88d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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.