GLYCOHEMOGLOBIN-SKREEN TEST KIT— 510(k) K780819

Name: FDA 510(k) clearance K780819
Creator: U.S. Food and Drug Administration
Published: 1978-11-07

Substantially Equivalent

Eppendorf-Brinkmann, Inc.

FDA 510(k) clearance K780819 for GLYCOHEMOGLOBIN-SKREEN TEST KIT, Substantially Equivalent on 1978-11-07. Applicant: Eppendorf-Brinkmann, Inc.. Device class: 2.

Clearance details

Applicant: Eppendorf-Brinkmann, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1978-05-17
Decision date: 1978-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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