CREATININE 340 (ENZYMATIC)— 510(k) K895847

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K895847 for CREATININE 340 (ENZYMATIC), Substantially Equivalent on 1989-10-30. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1989-10-03
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.