LDH REAGENT SYSTEM— 510(k) K781765

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K781765 for LDH REAGENT SYSTEM, Substantially Equivalent on 1978-11-22. Applicant: American Monitor Corp.. Device class: 2.

Clearance details

Applicant
American Monitor Corp.
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
Mchenry, IL, US
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