URS-1K (KETONE TESST)— 510(k) K003987

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K003987 for URS-1K (KETONE TESST), Substantially Equivalent on 2001-04-26. Applicant: Teco Diagnostics.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JIN
Advisory panel: Clinical Chemistry
Date received: 2000-12-26
Decision date: 2001-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

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