KING DIAGNOSTICS ALT (GPT) REAGENT— 510(k) K922109

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K922109 for KING DIAGNOSTICS ALT (GPT) REAGENT, Substantially Equivalent on 1992-06-04. Applicant: King Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant
King Diagnostics, Inc.
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
Indianapolis, IN, US
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