RH-HR NEGATIVE CONTROL REAGENT— 510(k) K800239

Name: FDA 510(k) clearance K800239
Creator: U.S. Food and Drug Administration
Published: 1980-02-21

Substantially Equivalent

Gotham Biologics, Inc.

FDA 510(k) clearance K800239 for RH-HR NEGATIVE CONTROL REAGENT, Substantially Equivalent on 1980-02-21. Applicant: Gotham Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Gotham Biologics, Inc.
Product code: Code KSF
Device class: Class 2
Regulation: 21 CFR 864.9650
Advisory panel: Hematology
Date received: 1980-02-05
Decision date: 1980-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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