Cleared Traditional

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

K802622 · Syva Co. · Toxicology device
Oct 1980
Decision
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Days
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Risk

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.

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 —

Device Classification

Product Code —
Device Class —