LACTATE DEHYDROGENASE COLORIMETRIC SUB.— 510(k) K780080

Name: FDA 510(k) clearance K780080
Creator: U.S. Food and Drug Administration
Published: 1978-02-07

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K780080 for LACTATE DEHYDROGENASE COLORIMETRIC SUB., Substantially Equivalent on 1978-02-07. Applicant: Corning Medical & Scientific. Device class: 2.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code CFE
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1978-01-16
Decision date: 1978-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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