UNI-FAST LACTATE DEHYDROGENASE (LDH-L)— 510(k) K872030

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K872030 for UNI-FAST LACTATE DEHYDROGENASE (LDH-L), Substantially Equivalent on 1987-07-07. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant
Sclavo, Inc.
Product code
Code CFJ
Device class
Class 2
Regulation
21 CFR 862.1440
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wayne, NJ, US
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