Cleared Traditional

K900983 - TRI-TECH URINE SPECIMEN KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K900983 · Tri-Tech, Inc. · Chemistry device
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Sep 1990
Decision
199d
Days
Class 1
Risk

K900983 is an FDA 510(k) clearance for the TRI-TECH URINE SPECIMEN KIT. Classified as Container, Specimen, Sterile (product code FMH), Class I - General Controls.

Submitted by Tri-Tech, Inc. (Potomac, US). The FDA issued a Cleared decision on September 17, 1990 after a review of 199 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.3250 - 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 Tri-Tech, Inc. devices

Submission Details

510(k) Number K900983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date September 17, 1990
Days to Decision 199 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 88d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMH Container, Specimen, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3250
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.