Cleared Traditional

EMIT-STM URINE CONTROLS (K802622) - FDA 510(k) Clearance

K802622 · Syva Co. · Toxicology device
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Oct 1980
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K802622 is an FDA 510(k) clearance for the EMIT-STM URINE CONTROLS.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1980.

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.

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Submission Details

510(k) Number K802622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received October 20, 1980
Decision Date October 20, 1980
Days to Decision -
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -