REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1— 510(k) K760195

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K760195 for REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1, Substantially Equivalent on 1976-08-03. Applicant: Coulter Electronics, Inc.. Device class: 1.

Clearance details

Applicant
Coulter Electronics, Inc.
Product code
Code CDT
Device class
Class 1
Regulation
21 CFR 862.1705
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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