WAKO R-GTP C-TEST— 510(k) K831639

Substantially Equivalent

Wako Chemicals USA, Inc.

FDA 510(k) clearance K831639 for WAKO R-GTP C-TEST, Substantially Equivalent on 1983-07-18. Applicant: Wako Chemicals USA, Inc.. Device class: 1.

Clearance details

Applicant
Wako Chemicals USA, Inc.
Product code
Code JPZ
Device class
Class 1
Regulation
21 CFR 862.1360
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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