P1 BLOOD GROUP SUBSTANCE— 510(k) K800916

Name: FDA 510(k) clearance K800916
Creator: U.S. Food and Drug Administration
Published: 1980-05-08

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K800916 for P1 BLOOD GROUP SUBSTANCE, Substantially Equivalent on 1980-05-08. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code KSX
Device class: Class 2
Regulation: 21 CFR 864.9160
Advisory panel: Hematology
Date received: 1980-04-22
Decision date: 1980-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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