Cleared Traditional

K983790 - VISUALINE II (ALSO KNOWN AS SUNLINE) PH...

K983790 · Sun Biomedical Laboratories, Inc. · Toxicology device
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Mar 1999
Decision
125d
Days
-
Risk

K983790 is an FDA 510(k) clearance for the VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Sun Biomedical Laboratories, Inc. (Blackwood, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel. 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sun Biomedical Laboratories, Inc. devices

Submission Details

510(k) Number K983790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1998
Decision Date March 01, 1999
Days to Decision 125 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 87d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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