ALT-30, 60 AND 100— 510(k) K861366

Substantially Equivalent

Dimension Diagnostics

FDA 510(k) clearance K861366 for ALT-30, 60 AND 100, Substantially Equivalent on 1986-06-25. Applicant: Dimension Diagnostics. Device class: 1.

Clearance details

Applicant
Dimension Diagnostics
Product code
Code CKA
Device class
Class 1
Regulation
21 CFR 862.1030
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Peters, MO, US
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