Cleared Traditional

K843382 - UROCYSTIN

K843382 is an FDA 510(k) clearance for UROCYSTIN, manufactured by Mission Pharmacal Co.. The device is a Class 1 Chemistry device with product code JLC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K843382 · Mission Pharmacal Co. · Chemistry device
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Jan 1985
Decision
133d
Days
Class 1
Risk

K843382 is an FDA 510(k) clearance for the UROCYSTIN. Classified as Nitroprusside Reaction (qualitative, Urine), Cystine (product code JLC), Class I - General Controls.

Submitted by Mission Pharmacal Co. (San Antonio, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1240 - 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 Mission Pharmacal Co. devices

FDA 510(k) Submission Details - K843382

510(k) Number K843382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date January 08, 1985
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

JLC Device Classification - Class 1, General Controls

Product Code JLC Nitroprusside Reaction (qualitative, Urine), Cystine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1240
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.