PROC APC ASSAY, PROC CONTROL PLASMA— 510(k) K962968

Name: FDA 510(k) clearance K962968
Creator: U.S. Food and Drug Administration
Published: 1996-12-13

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K962968 for PROC APC ASSAY, PROC CONTROL PLASMA, Substantially Equivalent on 1996-12-13. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1996-07-30
Decision date: 1996-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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