SULFATE, FIBRIQUIK PROTAMINE— 510(k) K781814

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K781814 for SULFATE, FIBRIQUIK PROTAMINE, Substantially Equivalent on 1978-11-08. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant
General Diagnostics
Product code
Code JBN
Device class
Class 2
Regulation
21 CFR 864.7300
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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